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Supplement to June 15, 2011Volume 91Number 11S

The Official Journal of the Transplantation Societywww.transplantjournal.com

Contents

- Note from the Secretariat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S27

- The Madrid Resolution on Organ Donation and Transplantation . . . . . . . . . . . . . . . . . . . . S29

- Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S32

- Report of the Madrid Consultation Part 1: European and Universal Challenges in OrganDonation and Transplantation, Searching for Global Solutions . . . . . . . . . . . . . . . . . . . S39

- Report of the Madrid Consultation Part 2: Reports from the Working Groups . . . . . . . . . S67

- Working Group 1: Assessing Needs for Transplantation. . . . . . . . . . . . . . . . . . . . . . . . . . . S67

- Working Group 2: System Requirements for the Pursuit of Self-Sufficiency . . . . . . . . . . . S71

- Working Group 3: Meeting Needs through Donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S73

- Working Group 4: Monitoring Outcomes in the Pursuit of Self-Sufficiency . . . . . . . . . . . S75

- Working Group 5: Fostering Professional Ownership of Self-Sufficiency in the EmergencyDepartment and Intensive Care Unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S80

- Working Group 6: The Role of Public Health and Society in the Pursuit ofSelf-Sufficiency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S82

- Working Group 7: Ethics of the Pursuit of Self-Sufficiency . . . . . . . . . . . . . . . . . . . . . . . . . S87

- Working Group 8: Effectiveness in the Pursuit of Self-Sufficiency - Achievements andOpportunities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S89

- Appendix 1: Expanded report on System Requirements for the Pursuit ofSelf-Sufficiency (Working Group 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S94

- Appendix 2: The Critical Pathway for Organ Donation after Death . . . . . . . . . . . . . . . . . . S102

- Glossary of Terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . S111

Transplantation�

ParticipantsOrganizers: Steffen Groth and Luc Noel, WHO; Rafael Matesanz and Beatriz Dominguez-Gil, ONT; Jeremy Chapman and

Francis Delmonico, TTS.Working Group Leaders:Group 1: Assessing Needs for Transplantation; Christian Jacquelinet (France), Adeera Levin (Canada), Jha Vivekanand

(India);Group 2: System Requirements for The Pursuit Of Self-Sufficiency, Curie Ahn (Korea), Martin Alejandro Torres (Argen-

tina), Jose Ramon Nunez (Spain);Group 3: Meeting Needs through Donation: Francis Delmonico (United States), Beatriz Dominguez-Gil (Spain), Faissal

Shaheen (Saudi Arabia);Group 4: Monitoring Outcomes in the Pursuit of Self-Sufficiency: John Gill (Canada), Axel Rahmel (The Netherlands),

Naoshi Shinozaki (Japan);Group 5: Fostering Emergency Department and IC Professional Ownership of Self-Sufficiency: Alexander Capron (United

States), Alex Manara (United Kingdom), Gerry O’Callaghan (Australia);Group 6: The Role of Public Health and Society in the Pursuit Of Self-Sufficiency: Jeremy Chapman (Australia), Gregorio

Obrador (Mexico), Harjit Singh (Malaysia);Group 7: Ethics of the Pursuit of Self-Sufficiency: Nikola Biller Andorno (Switzerland), Rudolf Garcia-Gallont (Guatemala),

Farhat Moazam (Pakistan);Group 8: Effectiveness in the Pursuit of Self-Sufficiency, Achievements, and Opportunities: Luc Noel (WHO), Chris Rudge

(United Kingdom), Anantharaman Vathsala (Singapore).Rapporteurs of the Consultation: Beatriz Dominguez-Gil (Spain); Martı Manyalich (Spain); Dominique Martin (Australia);

Sarah White (Australia), Lead Rapporteur and Editor.Other participants: Carmel Joseph Abela (Malta), Maria Joao Aguiar (Portugal), Adewale Akinsola (Nigeria), Mustafa

Al-Mousawi (Kuwait), Ines Alvarez Saldıas (Uruguay), Manuel Arias Rodriguez (Spain), Tamar Ashkenazi (Israel), GloriaAshuntantang (Cameroon), Danica Avsec-Letonja (Slovenia), Mohamed Salah Ben Ammar (Tunisia), Pavel Brezovsky(Czech Republic), Mirela Busic (Croatia), Mar Carmona (WHO), Leen Coene (Belgium), Elisabeth Coll (Spain), FionaConstable (WHO), Filip Danninger (Slovak Republic), Gabriel Danovitch (United States), Miguel Angel De Frutos Sanz(Spain), Francisco Jose Del Rıo (Spain), Roser Deulofeu (Spain), Visist Dhitavat (Thailand), Jose Luis Di Fabio (WHO),Boucar Diouf (Senegal), Peter Doyle (United Kigdom), Valter Duro Garcia (Brazil), Teodora Dzhaleva (Bulgaria), EhtuishEhtuish (Libyan Arab Jamahiriya), Linda Ezekiel (Tanzania), Serguei Gautier (Russian Federation), Gayatri Ghadiok (WHO),Athina Gompou (Greece), Carl Groth (Sweden), Niels Grunnet (Denmark), Sudhir Gupta (India), Valentina Hafner (WHO),Mohamed Hilal Abdou (Egypt), Arnt Jakobsen (Norway), Gunter Kirste (Germany), Anni Kuusvek (Estonia), Tong KiatKwek (Singapore), George Kyriakides (Cyprus), Ko Kyung Soon (Republic Of Korea), Mirjana Lausevic (Serbia), AlanLeichtman (United States), Sveinn Magnusson (Iceland), Beatriz Mahillo (Spain), P.G. Mahipala (Sri Lanka), Rui Maio(Portugal), Terence P. Mangan (Ireland), Rosario Marazuela (Spain), Trevor B. McCartney (Jamaica), Geeta Mehta (WHO),Nabila Metwalli (WHO), Marina Minina (Russian Federation), Fernando Morales Billini (Dominican Republic), EnriqueMoreno (Spain), Ferdinand Muehlbacher (Austria), Elmi Muller (South Africa), Alessandro Nanni Costa (Italy), Howard M.Nathan (USA), Jean-Bosco Ndihokumbayo (WHO), Alejandro Nino Murcia (Colombia), Gerry O’Callaghan (Australia),Kevin O’Connor (United States), Izaaq Odongo (Kenya), Freda O’Neill (Ireland), Arie Oosterlee (The Netherlands), Marie-Odile Ott (Council Of Europe), Ole Øyen (Norway), Anna Pavlou (European Commission), Ferenc Perner (Hungary), LolaPerojo (Spain), Francesco Procaccio (Italy), Rosana Reis Nothen (Brazil), Oleg Reznik (Russian Federation), S. Adibul HasanRizvi (Pakistan), Jose Luis Rojas (Chile), John Rosendale (United States), Wojciech Rowinski (Poland), Rafail Rozental(Latvia), Bassam Saeed (Syrian Arab Republic), Kaija Salmela (Finland), Jacinto Sanchez Ibanez (Spain), Manav Saxena(Singapore), Hans J. Schlitt (The Netherlands), Vijay Sharma (Nepal), Rakesh Kumar Srivastava (India), Endang Susalit(Indonesia), Zoltán Szabo (Hungary), Shiro Takahara (Japan), Annika Tibell (Sweden), George Tsoulfas (Greece), AndresValdivieso Lopez (Spain), Koenraad Vandewoude (Belgium), Ernie Vera (Philippines), Andi Wahyuningsih (Indonesia),Haibo Wang (People’s Republic of China), Lori J. West (United States), Daniel Wikler (United States), Liu Yongfeng (People’sRepublic of China), Kimberly Young (Canada), Victor-Gheorghe Zota (Romania), Gerson Zafalon (Brazil), Zhongyang Shen(People’s Republic Of China).

© WORLD HEALTH ORGANIZATION 2011. All rights reserved.The World Health Organization has granted the publisher permission for the reproduction of this supplement.Copyright in the typographical arrangement, design, and layout resides with the publisher Lippincott Williams &Wilkins.The authors alone, whether they are staff members of the World Health Organization or not, are responsible for theviews expressed in this publication, and they do not necessarily represent the decisions, policy or views of the WorldHealth Organization.

Third WHO Global Consultation on Organ Donationand Transplantation: Striving to Achieve

Self-Sufficiency, March 23–25, 2010, Madrid, Spain

NOTE FROM THE SECRETARIATThe Third World Health Organization (WHO)

Global Consultation on Organ Donation and Transplan-tation was organized by the WHO, The TransplantationSociety (TTS), and the Organizacion Nacional de Tras-plantes (ONT). The partnership among the three organi-zations made the best of their complementarities, and theutmost recognition and gratitude go to Rafael Matesanz(Director, ONT), Beatriz Domínguez-Gil (Medical Offi-cer, ONT), Jeremy Chapman (President, TTS), and FrancisDelmonico (Director of Medical Affairs, TTS) for theirrespective roles in advancing this significant and industri-ous collaboration. The main goal of the Consultation wasto discuss the concept of national self-sufficiency in organdonation and transplantation and to outline strategies bywhich this goal might be achieved.

The Consultation took place at a critical moment fortransplantation both at the European Union (EU) and at aglobal level. The draft Directive on Quality and SafetyStandards of Human Organs Intended for Transplantationwas discussed at the European Council and the EuropeanParliament. “Trilogues” including the European Commis-sion were about to start, and there was a political will toreach a first-reading agreement on the legal text. This first-reading agreement was finally reached in May 2010, theDirective to be transposed to the national legislation ofthe 27 EU Member States (MS) in the following 2 years.The Consultation also preceded the discussion by theWorld Health Assembly (WHA) of the updated WHOGuiding Principles for Human Cell, Tissue and OrganTransplantation following their endorsement by the Exec-utive Board of WHO in January 2009. In May 2010, the63rd World Health Assembly endorsed the Guiding Prin-ciples through Resolution 63.22. This resolution urgedMS, inter alia, “to strengthen national and multinationalauthorities and/or capacities to provide oversight, organi-zation and coordination of donation and transplantationactivities, with special attention to maximize donationfrom deceased persons and to protect the health and wel-fare of living donors with appropriate healthcare servicesand long-term follow-up.” The resolution, therefore,echoes the main conclusions of the Third WHO GlobalConsultation on Organ Donation and Transplantation.

In July 2008, the Declaration of Istanbul on OrganTrafficking and Transplant Tourism was promulgatedby TTS and the International Society of Nephrology (ISN).The Declaration recognizes the importance of self-sufficiency in

organ transplantation as the optimal approach to preventunethical practices in organ transplantation such as com-mercialism, organ trafficking, and transplant tourism. Theaim of the Madrid meeting was to identify the factors nec-essary to best meet population needs for transplantationand to propose practical and immediate recommendationsfor society, health authorities, and international organiza-tions. Striving for self-sufficiency has the potential toimpact health systems from the delivery of preventive in-terventions to tertiary medical services; at a societal scale,self-sufficiency promotes community values such as soli-darity and reciprocity. The outcomes of the Consultationestablish the practical, ethical, and philosophical groundon which self-sufficiency may be understood and illumi-nate the path to greater global equity in access to trans-plantation, most critically with respect to the central roleof donation from deceased donors.

Prior to the Consultation, eight working groups wereformed. Group members were chosen to represent a variety ofbackground and expertise, including representatives of healthauthorities and clinicians with different specialties and geo-graphical origins, to provide an interdisciplinary understandingof key issues relating to organ donation and transplantation.Three individuals within each group were designated to lead thepreparation of an aide memoire in advance of the Consulta-tion. These documents were discussed and refined during themeeting and were put forward for wider discussion in a ple-nary session. The body of evidence collated in these docu-ments by the participants of the Consultation, and the recom-mendations contained therein, form the basis of the MadridResolution. The Madrid Resolution (1) identifies the com-mon challenges facing transplantation in all countries andacknowledges the unique issues of particular societies andregions and (2) provides a diverse body of recommendationsto governments, international organizations, and healthcareprofessionals for the successful pursuit of the goal of self-sufficiency in organ donation and transplantation.

This report of the Third WHO Global Consultation onOrgan Donation and Transplantation is structured in threeparts. First, the final Madrid Resolution and Executive Summaryare presented, which crystallize the central recommendations toemerge from the Consultation. Second, the proceedings of allplenary sessions are summarized to provide a global overview ofcurrent challenges and a comprehensive report on the status oftransplantation activities in 2010. Third, the eight aide memoiresof the working groups are presented in full, with supplementaryinformation in related annexes. This report is intended as animmediate resource for policy makers and as a guide for practicalinitiatives. It is hoped that the challenges described will also in-spire further work in this emerging and important field withimplications for healthcare systems.

The Third WHO Global Consultation hence ad-dressed the concept of self-sufficiency in organs for trans-plantation in a comprehensive way for the first time. The

© World Health Organization 2011. All rights reserved.The World Health Organization has granted the publisher permission for the

reproduction of this supplement. Copyright in the typographical arrange-ment, design, and layout resides with the publisher Lippincott Williams &Wilkins.

ISSN 0041-1337/0-2000/00-27DOI: 10.1097/TP.0b013e3182190b29

Transplantation • Volume 91, Number 11S, June 15, 2011 www.transplantjournal.com | S27

http://www.transplantjournal.com

Madrid Resolution recognizes that organ donation andtransplantation are more than a good gesture and a medi-cal service and must involve all citizens. The pursuit ofself-sufficiency relies on a communal appreciation of thevalue of organ donation after death. It is an example of thepublic health and community values of reciprocity andsolidarity; moreover, it is the only safeguard against thetemptation of yielding to trade in human organs.

The Secretariat wishes to acknowledge the close andfruitful collaboration between the co-organizers of theconsultation, the invaluable support of the Government ofSpain, at the time holding the Presidency of the Council ofMinisters of the EU and the decisive contribution of theEuropean Commission Directorate General for Health andConsumer Policy (DG SANCO). The concepts and prepa-ration for this meeting were brought together from May2009 onward by Alex Capron, Jeremy Chapman, FrancisDelmonico, Beatriz Domínguez-Gil, and Dominique Mar-tin, and we are very grateful to them for their hard work.

We are indebted to the leaders of the working groupsfor their dedication and talent in preparing and developingthe basis for this consultation: Curie Ahn, Nikola Biller-Andorno, Alex Capron, Jeremy Chapman, Francis Del-monico, Beatriz Domínguez-Gil, Rudolf Garcia, John Gill,Christian Jacquelinet, Vivekanand Jha, Adeera Levin, AlexManara, Farhat Moazam, Jose Ramon Nunez, Gregorio Ob-rador, Gerry O’Callaghan, Axel Rahmel, Chris Rudge, Faissal

Shaheen, Naoshi Shinozaki, Harjit Singh, Martin AlejandroTorres, and Anantharaman Vathsala.

We would also like to acknowledge the efficacy andwisdom of those who accepted the task of chairing ses-sions: Gunter Kirste, Jeremy Chapman, Peter Doyle, Carl-Gustav Groth, Rafael Matesanz, Enrique Moreno, ArieOosterlee, and Jean-Marc Spieser. Special thanks are owedto Beatriz Domínguez-Gil, Martí Manyalich, DominiqueMartin, and Sarah White, rapporteurs of the Consultation,who captured the main features and products of the Con-sultation and prepared the present report. Sarah White puttogether and edited the present report and deserves thethanks of all involved in the consultation.

The preparation and the logistics of the meeting, soessential to its success, owes much to Lola Perojo and theONT team; Filomena Picciano and her team at TTS office;and Mar Carmona, Fiona Constable and Chris Faivre-Pierret atWHO to whom we want to express our gratitude. Thisreport represents the views of the participants not neces-sarily those of WHO. All the participants in the consulta-tion should be thanked for their active participation andtheir will to achieve consensus. The report was submittedto all participants for comment. We are grateful to themfor their input. Any error or omissions are, of course, ourresponsibility not theirs.

Luc Noël, Coordinator, WHO, Department of EssentialHealth Technologies (HSS/EHT/CPR).

S28 | www.transplantjournal.com Transplantation • Volume 91, Number 11S, June 15, 2011


The Madrid Resolution on Organ Donation andTransplantation

National Responsibility in Meeting the Needs ofPatients, Guided by the WHO Principles

The Third Global Consultation on Organ Donation andTransplantation was organized by the WHO in collabo-

ration with the ONT and TTS and supported by the EuropeanCommission. The Consultation, held in Madrid on March 23to 25, 2010, brought together 140 government officials, ethi-cists, and representatives of international scientific and med-ical bodies from 68 countries.

Participants in the Madrid Consultation urged theWHO, its MS, and professionals in the field to regard organdonation and transplantation as a part of every nation’s re-sponsibility to meet the health needs of its population in acomprehensive manner and address the conditions leading totransplantation from prevention to treatment. Donationfrom deceased persons, as a consequence of death determinedby neurologic criteria (brain death) or by circulatory criteria(circulatory death), was affirmed as the priority source oforgans and as having a fundamental role in maximizing thetherapeutic potential of transplantation.

Every country, in light of its own level of economic andhealth system development, should progress toward theglobal goal of meeting patients’ needs based on the resourcesobtained within the country, for that country’s population,and through regulated and ethical regional or internationalcooperation when needed. The strategy of striving for self-sufficiency encompasses the following features: actionsshould (1) begin locally, (2) include broad public health mea-sures both to decrease the disease burden in a population andto increase the availability of organ transplantation, (3) en-hance cooperation among the stakeholders involved, and (4)be carried out based on the WHO Guiding Principles and the

Declaration of Istanbul, in particular emphasizing voluntarydonation, non-commercialization, maximization of dona-tion from the deceased, support for living kidney donation,and meeting the needs of the local population in preference to“transplant tourists.”

This new paradigm calls for the development of acomprehensive strategic framework for policy and practice,directed at the global challenges created by an increasing in-cidence of chronic diseases and a shortage of organs for trans-plantation. Self-sufficiency advocates national accountabilityfor the establishment of an effective planning context for dis-eases treatable through organ transplantation and character-ized by adequate capacity management, regulatory control,and an appropriate normative environment (Fig. 1).

1. National capacity management involves: (a) developmentof an adequate and appropriate healthcare infrastructureand workforce consistent with the country’s level of devel-opment and economic capacity; (b) adequate and appro-priate financing of organ donation and transplantationprogramme; and (c) management of need by investmentin chronic disease prevention and vaccination.

2. National regulatory control consists of (a) adequatelegislation, covering declaration of death, organ pro-curement, fair and transparent allocation, consent, es-tablishment of transplant organizations, and penaltiesfor organ trafficking and commercialization; (b) regu-lations covering procedures for organ procurement, re-imbursement, and allocation rules; and (c) systems formonitoring and evaluation, including traceability and

FIGURE 1. Schematic representation of the concept of national accountability in meeting the donation and transplanta-tion needs of the population. CKD-chronic kidney disease; CVD-cardiovascular disease; COPD-chronic obstructive pulmo-nary disease.

© 2011 Lippincott Williams & Wilkins S29

surveillance, and for enabling evaluation of programmeperformance.

3. National authorities need to lead normative change,from a perception of organ donation as a matter of therights of donor and recipient to one of responsibilityacross all levels of society, through unambiguous legis-lation, committed support, and ongoing education andpublic information campaigns. Meeting needs of pa-tients while avoiding the harms of transplant tourismand commercial donation from living persons is an eth-ical imperative that relies on the assumption of a collec-tive responsibility for donation after death by all citizensand residents, thereby contributing to the commongood of transplantation for all.

The health of all populations will benefit from acomprehensive response to diseases contributing to end-stage organ failure, from prevention to access to effectiveorgan transplantation programmes made possible by a suf-ficient supply of donor organs. There is also a strong eco-nomic imperative to improve rates of transplantation andtherefore organ donation: kidney transplantation is lesscostly to provide than dialysis, and therefore, maximizingrates of kidney transplantation would significantly reduceoverall expenditure on renal replacement therapies. Kid-ney transplantation also results in better survival and qual-ity of life outcomes and enables greater productivity andcommunity participation. The perception of organtransplantation as an expensive and luxury clinical prac-tice is invalid; rather it is cost effective, mainstream, and acardinal feature of comprehensive health services. Beyondthe unmistakable medical benefits to patients affected byend-stage organ failure, organ transplantation is a key tothe challenge facing healthcare providers worldwide of un-sustainable expenditures on dialysis services and has po-tential to generate further practical consequences forhealth systems.

From a public perspective, the pursuit of self-sufficiencyrelies on a communal appreciation of the value of organ do-nation after death. The concept of donating human bodyparts to save the life of another as a civic gesture is one thatshould be taught at school alongside health education to de-crease the need for transplants. The pursuit of self-sufficiencyin organs for transplantation exemplifies the public healthand community values of equity, transparency, reciprocity,and solidarity, while it is the only safeguard against the temp-tation of yielding to trade in human organs.

In preparation for and during the meeting in Madrid,eight Working Groups identified specific goals and challengesand proposed solutions and recommendations from a num-ber of perspectives. The Working Groups identified the com-mon challenges faced by both developing and developedcountries, the unique issues of particular societies and re-gions, and provided a rich and extensive set of recommenda-tions directed at governments, international organizations,and healthcare professionals regarding how to best maximizedonations from deceased persons (including the develop-ment of The Critical Pathway for organ donation; Fig. 2) andhow to successfully progress toward meeting the needs ofpatients.

IMPLEMENTING SELF-SUFFICIENCY:RECOMMENDATIONS FROM THE

MADRID CONSULTATIONThe human right to health and dignity includes the recogni-

tion ofall human needs for transplantation. While self-sufficiency isconceived as a common global goal, the capacity to meet patients’needs should be found primarily within each country’s own re-sources, involving regulated regional or international cooperationwhen appropriate. The requirements of organ donation andtransplantation programmes with respect to resourcing, properorganization, regulation and the oversight of procurement, pro-cessing and transplantation of human body components fromliving and deceased persons are matters that rightly come underthe responsibility of governments, as outlined in ResolutionWHA57.18.

Consistent with the political and ethical obligations ofgovernments toward their citizens, the pursuit of self-sufficiency promotes the health and protects the interests ofpopulations. Although the practical implementation of self-sufficiency will vary for different countries, influenced by eco-nomic factors, health sector development, and existing healthpriorities, the inherent values of the self-sufficiency paradigmand the WHO Guiding Principles on human cells, tissues andorgans should guide organ donation and transplantation policyand practice in all contexts. The following overarching aspects ofself-sufficiency were identified during The Madrid Consultationas subject to specific recommendations:

Preventing the Need for Transplantation andIncreasing Organ Availability Are NationalResponsibilities

• Organ donation and transplantation have a role in thenational health policies of all countries, regardless ofcurrent transplant capability.

• Of equal importance to infrastructure and professionaldevelopment in organ donation and transplantation issustained investment in prevention to reduce futureneeds for transplantation, through intervention in themajor risk factors for end-stage organ failure and thedevelopment of health systems able to meet the chal-lenges of chronic diseases such as diabetes, cardiovascu-lar disease (CVD), and hepatitis.

• National transplantation legislation consistent with the WHOGuiding Principles is fundamental. It provides adequate pro-tection from exploitation and unethical practices and elimi-nates legislative impediments constraining the science andmedicine of donation from deceased persons.

• Public support for organ donation necessitates norma-tive change. To this end, education of the public shouldbegin in school, emphasizing individual and communityethical values such as solidarity and reciprocity. Self-sufficiency is founded in three main ethical premises:• The human right to health encompasses transplanta-

tion and disease prevention.• Organs should be understood as a social resource;

equity must therefore govern both procurementand allocation.

• Organ donation should be perceived as a civicresponsibility.



Donation and Transplantation ReflectComprehensive Health Care

• The critical functions of oversight, maintenance of pro-fessional standards and ethics, regulation, policy setting,and monitoring and evaluation of organ donation andtransplantation programmes are most effectively man-aged by a National Transplant Organization (NTO).

• Data registries are necessary for operational support(waiting list management and organ allocation) and formonitoring and surveillance of practices and outcomes.

• Monitoring and surveillance should encompass thefollowing data: national prevalence and incidence ofend-stage organ failure and diseases contributing toend-stage organ failure (need); availability of related in-frastructure and access to organ replacement therapies;outcomes of organ replacement therapy; acceptanceonto transplant waiting lists and time to receipt of anorgan; organ donation practices, standards and activities;practices, standards and activities in organ donation fromliving persons; and outcomes of transplantation (patientand graft survival). International harmonization of suchmetrics would facilitate comparisons between systems and

international benchmarking, identify regions in need ofdata, guide national policy making, and enable research.

Opportunities to Donate Should Be Provided inas Many Circumstances of Death as Possible

• The critical pathway provides a framework for the pro-cess of donation from deceased persons, which will aidglobal harmonization of practice.

• The key to self-sufficiency is maximizing donation fromdeceased persons: facilitating donation in as many cir-cumstances of death as possible, maximizing the out-comes from each donor, and optimizing the results oftransplantation. Donation after both brain death andcirculatory death should be regarded as ethically proper.Organ donation from living persons should be encouragedas complementary to donation after death, by providingappropriate regulatory frameworks and donor care.

• Physicians and nurses involved in acute care have a centralrole in identifying possible donors and facilitating donationafter death, and therefore should be supported by the nec-essary educational, technical, legal and ethical tools to as-sume leadership in this regard within their facility.

FIGURE 2. The critical pathway for organ donation. This figure was published in Transplant Int 2011; 24: 373–378. Thefigure has been reproduced with permission granted by Wiley-Blackwell.


Executive Summary

PREAMBLEIn response to the global disparities in access to trans-

plantation, a growing demand for organs, and the self-evidentharms of transplant tourism, a meeting of 140 representativesof international scientific and medical bodies, governmentofficials, and ethicists was held in Madrid, Spain, on March 23to 25, 2010. This Third Global Consultation was organized bythe WHO, TTS and ONT, and supported by the EuropeanCommission. The purpose of the meeting was to call for aglobal goal of national responsibility in satisfying organ do-nation and transplantation needs, with sufficiency based onresources obtained within a country for that country andthrough regulated and ethical regional or international coop-eration, when needed. The concept of a national responsibil-ity encompasses the following features: (1) action shouldbegin locally (not precluding international cooperation); (2)strategies should be targeted to decrease the transplantationneeds of a population and increasing organ availability, andshould enhance cooperation between stakeholders involved;(3) these strategies must be based on solid ethical principles:solidarity, voluntary donation, and non-commercialization(1); and (4) strategies should be tailored to the local realities.

The Third WHO Global Consultation carries forward theprinciples laid out in the WHO Guiding Principles for HumanCell, Tissue and Organ Transplantation, and the Declaration ofIstanbul on Organ Trafficking and Transplant Tourism (1, 2).The WHO Guiding Principles articulate the importance of pur-suing national or subregional self-sufficiency in organs for trans-plantation, in particular through increased efforts to promotedonation after death. The Declaration of Istanbul further statesthat “Jurisdictions, countries and regions should strive toachieve self-sufficiency in organ donation by providing a suffi-cient number of organs for residents in need from within thecountry or through regional cooperation.” The goal of the Ma-drid consultation was to confront the self-sufficiency paradigmfrom a practical perspective, developing a comprehensive strate-gic framework for policy and practice directed at the global chal-lenges of a shortage of organs for transplantation and unmetpatient needs. Therefore, the Madrid Resolution expresses botha pledge to progress in satisfying organ donation and transplan-tation needs, and a roadmap of how this may be achieved.

It was the intent that the consultation process should becomprehensive and holistic, encompassing different perspec-tives studied and discussed during the meeting. Eight differ-ent working groups were convened, with group memberschosen to represent a variety of different clinical experiencesand geographical regions, and to provide an interdisciplinaryunderstanding of the issues. The eight groups identified spe-cific goals and challenges, and proposed solutions and recom-mendations with respect to the following topics:

1. Assessing needs for transplantation2. System requirements3. Meeting needs through donation4. Monitoring outcomes5. Fostering professional ownership in the emergency de-

partment (ED) and intensive care unit (ICU)

6. The role of public health and society7. Ethics8. Measuring progress

Each group was led by three individuals, who inadvance of the meeting, worked together to guide the prepa-ration of a draft document for discussion and refinementduring the meeting. The outcomes of the working groupswere also discussed in a plenary session. The final eight doc-uments produced by the working groups complete the Ma-drid Resolution on Organ Donation and Transplantation andare based on a large body of evidence collected by participantsbefore the consultation and reflecting their particular experi-ences representing 68 nations. The Madrid Resolution identi-fies the common challenges faced by both developing anddeveloped countries, and the unique issues of particular soci-eties and regions, and provides a diverse body of recommen-dations to governments, international organizations, andhealthcare professionals regarding how to successfully meetthe needs of patients. This document represents an immedi-ate resource for policy makers and guide for practical initia-tives. It is hoped that the Madrid Resolution will also inspirenew work in this emerging and important field.

The ResolutionMeeting the needs of patients with respect to organ do-

nation and transplantation is a national responsibility thatshould be met primarily through a country’s own resources,with specific regulated and ethical regional or internationalcooperation when appropriate. National accountabilities canbe broadly defined as the creation of a national planning con-text for chronic diseases treatable through organ transplanta-tion that encompasses capacity control, regulatory control,and determination of the appropriate ethical environments.

1. National capacity control involves: (a) development ofadequate and appropriate healthcare infrastructure andworkforce development, consistent with developmentlevel and economic capacity; (b) adequate and appro-priate financing of organ donation and transplantationprogrammes; and (c) management of need by invest-ment in chronic disease prevention and vaccination.

2. National regulatory control consists of: (a) adequatelegislation, covering declaration of death, organ pro-curement, fair and transparent allocation, consent,establishment of transplant organizations, penalty oforgan trafficking, and commercialization; (b) regula-tion covering procedures for organ procurement, re-imbursement, and allocation rules; (c) systems formonitoring and evaluation, including traceabilityand surveillance, and enabling evaluation of pro-gramme performance.

3. National authorities need to lead normative change,from organ donation as a right of donor and recipient toa responsibility across all levels of society, through edu-cation, unambiguous legislation, and committed sup-port. Meeting needs of patients while avoiding theharms of transplant tourism and commercial donation



from living persons is an ethical imperative that relieson collective responsibility for donation after death,thereby contributing to the common good of transplan-tation for all. The WHO Guiding Principles for HumanCell, Tissue and Organ Transplantation provide thefoundation for all efforts toward progress in meetingtransplantation needs.

RecommendationsInforming The Resolution are the detailed recommen-

dations of the eight working groups convened as a part of theThird WHO Global Consultation on organ donation andtransplantation. The key recommendations of these workinggroups are as follows:

Recommendations With Respect to Assessment ofTransplantation Needs

1. True need for transplantation cannot be defined by avail-ability of treatment. Instead assessment of need must bemultifactorial and take into account:a. True incidence of end-stage organ failure, irrespective

of treatment availability (in all age groups and for allorgans).

b. Complexity of conditions and the drivers of need.c. Nonmedical factors (e.g., economic, cultural, attitudi-

nal, competing health priorities) that modify actualtransplant needs within that setting.

2. Internationally consistent definitions, data, and toolsneed to be developed to accurately and comprehen-sively measure transplantation needs, thereby enablinga broader understanding of the issues facing differentcountries and facilitating the identification of globalsolutions.

3. An international registry of organ donation and trans-plantation should be established. The following national-level data should be made available for this purpose:a. National prevalence and incidence of end-stage organ

failure and of diseases contributing to end-stage organfailure.

b. Availability of treatment for end-stage organ failure(transplant and non-transplant).

c. Waiting-list statistics, including “true” wait times.d. Progression and outcomes of organ dysfunction.e. Referral to organ replacement therapy (assist devises

and transplantation).f. Time to workup, time to acceptance onto the waiting

list, and time to receipt of an organ.

4. All countries should have the ability to assess their needsfor transplantation. Governments should:a. Support the identification of organ failure or replacement

needs as a priority for public health improvement;b. Allocate resources to registry development (opera-

tional and surveillance/monitoring) and furthermorecreate a registry for conditions leading to the need fororgan transplantation;

c. Invest in prevention programmes to reduce needs;d. Ensure the equity principle is applied in needs

assessment;

e. Create or support infrastructure and allotment of re-sources for all aspects of needs assessment.

5. With respect to needs assessment in transplantation,WHO should:a. Identify as a resolution that all countries shall have the

ability to assess their needs for transplantation by 2020;b. Identify and outline the need for the use of a core min-

imum dataset by which international comparisons willbecome meaningful.

6. Professional societies and healthcare providers should:a. Ensure consistency of definitions and use of metrics

with respect to registry data;b. Support identification of organ failure as a strategic

priority;c. Foster international enquiry, collaboration, and devel-

opment in the area of needs assessment;d. Promote and support education relating to needs as-

sessment, including technical advice regarding meth-odologies, data interpretation, and applications;

e. Promote scientific enquiry in the area of needs assess-ment, including validation studies;

f. Ensure linkages with governmental agencies and policymakers to support translation of research.

Recommendations With Respect to Systems andOrganization

1. Clear and unambiguous legislative and regulatory frame-works are the foundation on which successful systems fororgan donation and transplantation, based on ethical andtransparent practices with respect to organ procurement,recovery, allocation and transplantation, are built. Gov-ernments should therefore:a. Enact transplantation legislation consistent with the

WHO Guiding Principles. Legislation should address:• Standards for determining and declaring death;• Organ procurement from deceased and living persons;• Fair and transparent allocation to wait-listed patients,

based on medical criteria;• Respect for the wishes of the deceased concerning

consent;• Establishment of transplant organizations;• Prohibition of organ trafficking and commercialization.

Governments should also:b. Incorporate donation and transplantation into national

health policies as a priority;c. Support donation after death;d. Invest in basic infrastructure and professional training;e. Create a national waiting list and comprehensive regis-

try of donors and recipients;f. Create the necessary systems for ongoing regulation and

oversight to ensure transparency and facilitate review ofprogress and the implementation of new strategic poli-cies;

g. Lead public awareness of organ transplantation andcommit to public education.

2. NTOs responsible for coordination and oversight, ethicalpractice, regulation, policy setting, maintenance of na-tional data registries, and data protection are essential.Core functions are to include:


a. Surveillance of practices, standards, and outcomes inorgan donation and transplantation;

b. Assurance of ethically proper organ procurement andallocation, transparency of all organ donation andtransplantation processes, and traceability of donatedhuman materials;

c. Standardization of procedures and performance manage-ment of Organ Procurement Organizations (OPOs), re-lated non-government organizations (NGOs), individualtransplantation centers, ethics committees, and transplantteams;

d. Regulation and management of the reimbursement ofreasonable and verifiable expenses incurred by the livingdonor, and reimbursement of hospitals that incur costsin donating or procuring organs;

e. Oversight of the division of responsibilities acrossall organizations involved in organ donation andtransplantation;

f. Public endorsement of organ donation and transplanta-tion and support of the process with mass media educa-tion and promotion.

3. When organization is based on OPOs, these organizationsmanage procurement activities independently of hospitaltransplant units, subject to government approval andregulation. The nature of OPOs will vary according todifferent national requirements and realities, although theessential functions are the same in every setting, which areas follows:a. Surveillance and detection of possible/potential donors

at every acute care hospital.b. Donor management for the recovery of viable organs.c. Coordination of procurement, through a designated

Organ Procurement Coordinator (OPC).

4. Performance is dependent on successful integration andcoordination across systems. All countries performingtransplantation need to organize a unified coordinationthat regulates organ donation and transplantation pro-cesses. In addition, international coordination facilitatescross-border exchange of organs, information and re-search, and it is critical to combat organ trafficking andtransplant tourism.

Recommendations With Respect to Organ Donation

1. Countries and jurisdictions should aim to maximizedonation from deceased persons, maximize the out-come from each deceased donor, and optimize resultsof transplantation.a. Donation from deceased persons is a requirement;

transplantation activity cannot rely on living donors.b. Both donation after brain death (DBD) and donation

after circulatory death (DCD) are to be considered.c. Countries should enable transplants from living do-

nors, as complementary to donation from deceasedpersons, by providing appropriate ethical and legalframeworks and donor care.

2. Donation after death is a process, at any stage of whichlosses of potential donors may occur. Therefore, to maxi-mize donation from deceased persons, an organizational

approach should be adopted with explicitly defined ac-tions, roles, and responsibilities across the entire process.The Critical Pathway for organ donation is to be consid-ered a general framework of reference for systematizingthe deceased donation process. The objectives of The Crit-ical Pathway are as follows:a. To provide a common systematic approach to the pro-

cess of donation from deceased persons, both for DBDand DCD.

b. To create common triggers to facilitate the prospectiveidentification and referral of the possible deceased or-gan donor and precipitate the deceased donationprocess.

c. To provide common procedures to estimate the poten-tial of organ donation from deceased persons and eval-uate performance in the deceased donation process.

3. With respect to organ donation from deceased persons,governments should:a. Eliminate legislative impediments constraining the

medicine and science of donation from deceased per-sons and organ transplantation;

b. Provide adequate support (including financial sup-port) for organ donation from deceased persons andtransplantation programmes;

c. Ensure equitable access to transplantation therapiesand transparency of the system;

d. Through a NTO (see Recommendations with respectto Systems and Organization, number 2) provide over-sight and ensure the development and implementationof the following:• The Critical Pathway;• Protocols for all steps of the process of donation after

death, especially timely identification and referral;• Appointment of trained professionals, including donor

coordinators, who are accountable for performance;• A data registry for ongoing evaluation of donation

processes, estimation of the potential of donationfrom deceased persons, evaluation of overall perfor-mance, identification of areas for improvement, andfactors critical to success;

• Professional training and promotion of a nationalculture of donation.

4. With respect to donation from deceased persons, theWHO should:a. Promote the international implementation of The

Critical Pathway;b. Monitor the collection of relevant data assessing per-

formance in organ donation for internationalbenchmarking;

c. Foster regional cooperation in organ sharing that pre-serves equity between donor and recipient popula-tions, and the efficient transplantation of otherwisediscarded organs.

5. With respect to organ donation from deceased and livingpersons, healthcare professions should:a. Make every effort to maximize the number of organs

recovered and transplanted;b. Support and promote DCD;



c. Present the option of donation from living persons tofamilies, with all practices in the donation of organsfrom living persons consistent with the principles ofThe Declaration of Istanbul.

Recommendations With Respect to Monitoring ofOutcomes in the Pursuit of Self-Sufficiency

1. The purpose of registering data on transplant activitiesand outcomes is to identify areas in need of improvement;to enable system transparency, equity, and compliance;and to monitor system improvement both longitudinallywithin a given system and between systems through inter-national benchmarking. Registries should be not onlyconcerned with donors and recipients but also with infra-structure availability. They are a tool for quality assuranceand policy making, and registry data may furthermore beused to raise awareness of the need for organ donationamong the lay public and policy makers.

2. In all countries/regions, data should ideally be collected inthe following areas:a. Available infrastructure (hospital and organizational);b. Regulatory oversight and health policy;c. Current and likely future needs for transplantation;d. Access to the waiting list and to transplantation;e. Waiting-list outcomes;f. Travel for transplantation and transplant tourism;g. Organ donation from deceased persons;h. Organ donation from living persons; andi. Outcomes of transplantation (patient and graft survival).

3. Two complementary data collection systems are proposed:a. A national/regional system, which has operational

functions (allocation) and monitoring and evaluation.b. An international system with a global perspective, un-

der an International Data Group. The InternationalData Group would establish standardized definitions/metrics, provide assistance to national/regional regis-tries, facilitate comparisons between systems and inter-national benchmarking, identify regions in need ofdata, guide individual nations and systems, and facili-tate research into special patient groups where smallpatient numbers would otherwise be restrictive.

4. With respect to monitoring, governments should:a. Support national/regional registries with infrastruc-

ture and human resources;b. Establish responsibility for operation and governance

of this registry;c. Facilitate cooperation between government and NGOs

in monitoring outcomes and disseminating informa-tion to the scientific community, the public, and policymakers; and

d. Use registry data to assess the impact of policy changeand inform the need and direction of new legislationand policy.

5 Professionals and professional societies should:a. Provide content expertise;b. Cooperate on the consistency of data elements across

the continuum of organ failure (i.e., chronic kidneydisease, dialysis, and transplantation); and

c. Facilitate development of an International Data Groupfor the ongoing collection of data that will empowerindividual countries and regions in the pursuit ofself-sufficiency.

Recommendations With Respect to Fostering Emergencyand Intensive Care Department Professional Ownershipof Organ Donation

1. Organ donation is a different process than organ trans-plantation and requires different skills and personnel tomaximize its potential. Possible and potential deceaseddonors are found in the ICUs and increasingly in EDs.Physicians and nurses involved in acute care need to beaware of their critical role in identifying possible and po-tential donors and to be engaged in the development ofprogrammes for organ donation from deceased persons.Therefore, the pursuit of self-sufficiency requires ICU andED doctors and nurses to:a. Be aware of the need for organ donation and therefore

want to facilitate it;b. Know how to facilitate organ donation and have the

educational, technical, legal and ethical tools to do so;c. Be supported by their colleagues, hospitals and health

authorities in facilitating organ donation;d. Be recognized as experts in this area and in educating

their colleagues;e. Take the lead in enabling their facility to provide this

service, including appropriate counseling for families.

2. To foster professional ownership of self-sufficiency in theED and ICU, governments should:a. Under legal, ethical, and medical frameworks for prac-

tice, include:• Standards for determining death, enacted by the leg-

islature, and accepted by the profession and public;• Evidence-based tests and methods that physicians

can readily use to apply these standards in the EDand ICU;

• Clear statements, at institutional and governmentallevels, regarding the responsibility of various careproviders to donors and recipients.

b. Provide unambiguous guidance ensuring that indi-vidual medical staff involved in acute care are notpersonally or legally vulnerable when aiding the or-gan donation process.

3. Professional bodies should:a. Provide training and guidance for Emergency/Inten-

sive Care nurses and physicians, covering:• The need for organ donation and the importance of

the role of acute care physicians and nurses;• Identification of possible and potential donors;• Death determination;• Protocols on how treatment decisions (e.g., for pa-

tients with severe neurologic injuries) relate to donorstatus and to alternative (circulatory/respiratory andneurologic) bases for determining death;

• Protocols on how to manage the dying process for pa-tients whose deaths will be determined on circulatory/respiratory or neurological grounds, and on post-deathmaintenance of body;


• How to make donation an understandable and ac-ceptable choice for families of dying patients;

• Effective interaction with the OPO and transplanta-tion team.

b. Support the development of academic and scientificresearch activity in the emergency and intensive carecommunities to create a professional investment in thebest practice approaches that emerge.

4. Hospitals should:a. Give local ED and ICU staff “ownership” of solving the

problems and developing protocols for managing thecare of potential donors;

b. Identify individuals within the emergency or intensivecare team who can act as role models or “champions”to increase the profile of organ donation within thatfacility and provide education to the team on all rele-vant issues;

c. Appoint donor coordinators within hospitals to facili-tate communications among emergency and intensivecare staff, bereaved families and transplantationservices;

d. Include the possibility or potential for organ donationin every end-of-life care pathway in the ED/ICU;

e. Improve the interface between the ED/ICU and thelocal transplant team and responsible NationalAuthority;

f. Identify strategies to minimize the effects of lack of re-sources on the conversion of potential donors to actualdonors;

g. Audit outcomes of the donation process within eachfacility to allow identification of potential areas for im-provement, set achievable targets, and formally recog-nize excellence.

Recommendations With Respect to the Role of PublicHealth and Society

1. Roles for public health in the pursuit of self-sufficiencyinclude:a. Prevention of the frequent causes of end-stage organ

failure (diabetes, hypertension, alcohol abuse, hepatitisB virus [HBV], hepatitis C virus [HCV], coronary ar-tery disease [CAD], and chronic obstructive pulmonarydisease [COPD]), including primary, secondary, andtertiary prevention;

b. Promotion of organ donation among health profes-sionals and the general public;

c. Development of effective healthcare systems capable ofsupporting efficient organ procurement, equitable allo-cation, safety and quality, and national disease preven-tion programmes.

2. The act of donation is itself an individual decision thatinteracts with the social setting and the institutional andregulatory framework into which an individual is embed-ded. Family refusal, together with failure to identifypossible and potential donors, is the most significant im-pediment to increase rates of donation. Roles for society inthe pursuit of self-sufficiency include:a. Public education efforts to counter poor awareness, dis-

trust of medicine, and misconceptions about donationand transplantation, while instilling notions of reci-

procity, solidarity, and building public willingness tosupport organ donation;

b. Community funding for donation and transplantationthrough public finance and charitable sources.

3. Recommendations for public health:a. Reduce demand for transplantation by prevention of

major risk factors for end-stage organ failure and bydeveloping healthcare systems able to effectively andequitably meet the challenges of chronic diseases, par-ticularly diabetes and hypertension;

b. Develop awareness and increased willingness of medicalprofessionals to be involved in the donation and trans-plantation process, encourage a stakeholder role forICU/ED physicians, and develop specific educationprogrammes for primary care physicians, nurses, med-ical students, and allied health professionals;

c. Develop culturally sensitive awareness programmes,using public health methodologies to promote trust andstrengthen commitment to organ and tissue donationin the community;

d. Increase the efficiency of healthcare systems and trans-plant programmes by using private and non-govern-ment sources of funding as appropriate, and developingsynergies between the government and NGOs.

4. Recommendations for society:a. Provide regular and consistent normative change com-

munication programmes and culturally sensitiveawareness programmes directed at community andfaith-based organizations;

b. Provide public recognition of donors and their familiesand actively manage adverse publicity;

c. Ensure all aspects of donation and transplantation aretransparent to the public, and develop educational pro-grammes to dispel myths and misconceptions, takinginto account the range of community beliefs and values.

5. In settings where resource limitations and health sectordevelopment constrain the development of organ dona-tion and transplantation programmes, the prevention ofend-stage organ failure, within the context of wider publichealth goals, is crucial to self-sufficiency. In such settings,delivery of transplantation therapy may be approachedthrough locally relevant approaches to financing, usingboth private and non-governmental sources of funding,and developing synergies between governments, NGOs,and charities.

Recommendations With Respect to Ethics in the Pursuitof Self-Sufficiency

1. Self-sufficiency must be supported by normative change,reframing organ donation from a matter of the rights ofdonor and recipient, to a responsibility functioning at alllevels of society (individual, government, professional,etc). The self-sufficiency paradigm is based on three mainethical premises:a. The human right to health requires that governments

engage in prevention and providing transplantationservices. The responsible administration of scarce re-sources such as organs also encompasses concerted ac-



tions directed toward prevention of end-stage organfailure.

b. Organs should be understood as a social resource;therefore, equity should govern both procurement andallocation.

c. Organ donation should be perceived as a civic respon-sibility toward fellow citizens; in contrast, organmarkets and transplant tourism lead to morally unac-ceptable coercion and exploitation.

2. In accordance with The Declaration of Istanbul and theWHO Guiding Principles, self-sufficiency promotes thefollowing ethical principles:a. Minimizing harm/reducing suffering—both decreas-

ing need for transplantation and efforts to maximizethe number of organ available for transplantation areemphasized.

b. Justice—an equitable distribution of benefit and bur-den and the elimination of exploitation are central tothe self-sufficiency paradigm.

c. Respect for persons—self-sufficiency avoids undue in-centives while appealing to solidarity and civic respon-sibilities toward the community.

3. With respect to ethics and self-sufficiency:a. Governments/health authorities should be account-

able for the ethical integrity of organ donation andtransplantation systems;

b. Health professionals should receive training in theethical aspects of organ transplantation and be vigi-lant concerning unethical or illegal behavior, andprofessional societies should foster enquiry on ques-tions of culture, values, and ethics relating to self-sufficiency;

c. Civil society should establish an ethos of social re-sponsibility and solidarity in meeting the commu-nity’s transplantation needs through participation indonation after death, necessitating the engagementof community- and faith-based organizations andNGOs.

Overall Recommendations With Respect to EffectiveProgress in the Pursuit of Self-Sufficiency

1. The capability of individual countries/regions to meettransplantation needs is determined by economic re-sources, systems development, and existing health priori-ties. The minimum level of transplantation capability isdefined as the presence of a few medical professionals whohave the capability to provide appropriate presurgical andpostsurgical management of transplant recipients and liv-ing donors in a context of no local transplantation activity;maximum capability is defined as a comprehensive multi-organ transplant programme that provides an adequatesupply of transplantable organs to meet the needs of thepopulation. By defining successive levels of capability, theinclusive nature of the self-sufficiency paradigm isreinforced, and it is possible to describe a framework forevolution and achievement in organ donation and trans-plantation that is adaptable to all contexts.

2. The pursuit of self-sufficiency involves the developmentand implementation of strategies aimed at increasing na-

tional/regional transplantation capabilities to progressfrom one level of capability to the next, in a manner that isconsistent with local realties and does not distort existinghealth priorities. Countries/regions evolve toward greaterself-sufficiency in organ donation and transplantationthrough incremental achievements in each of the follow-ing domains:a. Resources and professional development for donation

and coordination;b. Legal and regulatory frameworks;c. Resources and professional development for transplant

services;d. Government and other resources;e. Community involvement;f. Assessment and minimization need for organs.

3. To enable evolution and achievement in transplantationcapability, Governments should:a. Acknowledge their responsibilities in managing end-

stage organ failure from prevention to treatment intheir population and designate a focal point/coordinat-ing authority;

b. Derive an integrated strategy for the care of patientswith end-stage organ failure, from prevention of organdisease and organ failure to replacement therapies includ-ing transplantation, to optimize the use of resources;

c. Include the elements of organ donation and transplan-tation in their national health plan and assess their ownlevel of transplantation capability;

d. Allocate resources, develop infrastructure, andstrengthen health systems to support the achieve-ment of these goals;

e. Report national data on organ donation and transplan-tation activities to the Global Observatory on Donationand Transplantation (GODT);

f. Participate in public education and engage profession-als, professional societies, NGOs, and the community;

g. Foster regional and international cooperation in thepursuit of these goals.

4. To support national/regional efforts to pursue self-sufficiency, WHO should:a. Urge MS to adopt and implement the principles of the

Madrid Resolution;b. Urge MS to self-assess their level of transplantation

capability, to aid the identification of areas forimprovement;

c. Monitor progress in levels of achievement in the pur-suit of self-sufficiency across MS:

d. Align the range of quantifiable indicators collected bythe GODT to the framework of the Madrid Resolution;

e. Develop international standards, guidelines, andtools, in collaboration with professional organiza-tions, for the advancement of transplantation policyand practice;

5. To support national/regional efforts to pursue self-sufficiency, professionals and professional societiesshould:a. Acknowledge their responsibilities with respect to their

own professional development, adoption of ethical


practices, maintenance of standards, and training fordonation and procurement;

b. International societies should support the establish-ment and work of the relevant national societies to fur-ther their missions with respect to organ donation andtransplantation;

c. Provide professional advice to MS and assistance forthe development of standards for accreditation andquality assurance;

d. Participate in professional and public education andengage other professionals and the public in the ad-vancement of organ donation and transplantation;

e. Encourage research, especially clinical research di-rected at maximizing benefits, minimizing costs, andoptimizing resource allocation in organ donation andtransplantation.

CONCLUSIONSThe Madrid Resolution on Organ Donation and

Transplantation recognizes that donation and transplanta-tion are more than a good gesture and a medical service.For patient needs to be met, all citizens and residents mustbe involved. From a public perspective, national attemptsto meet patient needs rely on a communal appreciation of

the value of organ donation. The concept of donating hu-man body parts to save the life of another as a civic gestureis one that should be taught at school as a part of healtheducation along with promotion of healthy life style. Theorganizational requirements and allocation of resourcesnecessary to maximize donation from deceased donorsand ensure equitable access to transplantation services,and the implementation of preventive interventions to al-leviate needs for transplants, mandate the active commit-ment of Government. The benefits to be gained extend waybeyond the successful transplantation of patients. The pur-suit of the goal of ensuring a national responsibility insatisfying the donation and transplantation needs of agiven population, outlined in the Madrid Declaration, hasthe capacity to strengthen the public health and commu-nity values of reciprocity and solidarity, while it is the onlysafe guard against the temptation of yielding to trade inhuman organs.

REFERENCES1. Steering committee of the Istanbul Summit. Organ trafficking and trans-

plant tourism and commercialism. The Declaration of Istanbul. Lancet,2008; 372: 5. Available at: http//www.declarationofistanbul.org.

2. WHO Guiding Principles; WHA 63.22/2010 Available at: http://www.who.int/transplantation/en/.


www.declarationofistanbul.org

http://www.who.int/transplantation/en/



Report of the Madrid ConsultationPart 1: European and Universal Challenges in OrganDonation and Transplantation, Searching for Global

Solutions

IntroductionDuring the past 50 years, the transplantation of hu-

man organs, tissues, and cells has become a worldwidepractice that has extended and greatly enhanced the qualityof hundreds of thousands of lives. Transplantation is thebest and most cost-effective treatment for end-stage kid-ney failure and remains the only available treatment forpersons with end-stage failure of other solid organs. Con-tinuous improvements in medical technology, particularlywith respect to organ and tissue rejection, have led to in-creased demand for organs and tissues. Despite substantialexpansion in organ donation from deceased persons inrecent years and greater reliance on donation from livingpersons, the availability of organs and tissues for trans-plantation remains insufficient to meet demand.

Global activities in organ donation and transplanta-tion are highly variable, resulting in gross inequities inaccess to transplantation therapies. Where transplantationservices are available, the great shortage of available organsin most jurisdictions means that many people in need areexcluded from waiting lists, others deteriorate or die whileawaiting transplantation, and some turn to desperate al-ternatives such as organ sales and transplant tourism.These unethical practices are addressed in The Declarationof Istanbul on Organ Trafficking and Transplant Tourismand in the WHO Guiding Principles for Human Cell, Tis-sue and Organ Transplantation (1, 2). For the govern-ments of most high-income countries, the consequence oforgan shortages has been a vast and escalating expenditureon kidney dialysis, despite dialysis therapy being more costlyand associated with poorer outcomes than kidney transplan-

tation. Given the manifest harms of transplant commercial-ization, global disparities in access to transplantation, the grow-ing demand for organs, and the enormity of costsassociated with dialysis provision, there is an urgent needfor new strategic approaches toward these challenges thatare capable of equitably meeting the organ transplantneeds of populations in reliable, sustainable, efficient, andeffective ways that do not compromise ethical principles.

The Third WHO Global Consultation on Organ Dona-tion and Transplantation (Madrid, March 23–25, 2010)brought together 140 representatives of international scien-tific and medical bodies, government officials, and ethicists,with the goal of confronting these shared challenges and de-veloping a comprehensive strategic response (the MadridResolution). The theme of the conference, “Striving toAchieve Self-Sufficiency,” refers to the practical and ethicalrequirement for jurisdictions, countries, and regions to takeaction to both reduce transplantation needs and optimize theresources available to meet them. The many facets— bothpractical and policy based— of the pursuit of self-sufficiencywere the focus of working group discussions. Broad represen-tation from different countries, clinical backgrounds, anddisciplines enabled a holistic appreciation of the issues.

Each working group produced detailed recommenda-tions that are reproduced in full in Part II of this report. Part Ipresents a comprehensive background to these recommenda-tions, being an account of the proceedings and plenary presen-tations of the Consultation. Proceedings were in four main parts:(1) a Round Table of European Ministries of Health to discussthe benefits of a common European strategy toward organ do-nation and transplantation; (2) a presentation of current chal-

From the Declaration of Istanbul on Organ Trafficking and Transplant Tourism:

Principles …Jurisdictions, countries, and regions should strive to achieve self-sufficiency in organ donation by providing a sufficient numnerof organs for residents in need from within the country or through regional cooperation. a. Collaborations between countries is not inconsistent with national self- sufficiency as long as the collaboration protects thevulnerable, promotes equality donor and recipient populations, and does not violate these principles. b. jurisdiction is only acceptable if it does not undermine a country’s ability to provide transplant services for its own population.

Proposals …Governments, in collaboration with health-care institutions, professionals, and appropriate actions to increase deceased organ donation. Measures should be taken to remove obstacles and disincentives to deceased organ donation. In countries without established deceased organ donation or transplantation, national legislation should be enacted that would initiate deceased organ donation so as to fulfill each country’s deceased donor potential.

the therapeutic potential of deceased organ donation andtransplantation should be maximized.

deceased donor transplant programmes are encouraged to share information, expertise, and technology with countries seeking to improve their organ donation efforts…

betweenTreatment of patients from outside the country or

non-governmental organizations, should take

and create transplantation infrastructure,In all countries in which deceased organ donation has been initiated,

Countries with well-established


lenges and initiatives in organ donation and transplantation inthe EU, including a presentation of the European legislativeframework on quality and safety aspects of organ donation andtransplantation (The Directive on Quality and Safety Standardsof Human Organs Intended for Transplantation) and its associ-ated Action Plan; (3) introduction of the concept of self-suffi-ciency in organ donation and transplantation and discussion ofits role within the agenda of the WHO, followed by an examina-tion of the responsibilities of health authorities and professionalsocieties in furthering the pursuit of self-sufficiency; and (4) aglobal overview of the current state of affairs in organ donationand transplantation, with representation from each of the sixWHO regions.

In the context of organ donation and transplantation,“self-sufficiency” refers to the adequate and equitable provisionof transplantation services and human organs to satisfy the or-gan transplantation needs of a given population, using resourcesobtained from within that population or provided through re-gional cooperation. There was extended discussion during theMadrid Consultation regarding the ability of the term self-sufficiency to adequately capture the full implications ofwhat is involved in satisfying the organ transplantation needs ofpopulations. In particular, there was concern that the impor-tant role of ethical and regulated regional or internationalcooperation in some jurisdictions, and the globally collabor-ative nature of the pursuit of self-sufficiency, would not besatisfactorily conveyed in the subsequent use of the term.

In the weeks and months after the Madrid Consulta-tion, it became evident that self-sufficiency appropriately en-capsulates the conception of donation and transplantationthat we intended to promote. Scientific and professional so-cieties include self-sufficiency in the agenda of their con-gresses, and representatives of MS used it during the lastWHA. The term functions as intended; striving toward self-sufficiency is a rallying standard for a new paradigm in the con-ception of organ donation and transplantation that:

• Is applicable at jurisdictional level, where the authorityand power of health policy implementation lies, andwhere agreements between small countries with respectto regional cooperation are made;

• Is inclusive of all those in need of transplantation, andalso places the burden of donation on all, whenevermedically and ethically possible;

• Promotes societal values and community ethicalprinciples;

• Promotes integrated end-stage organ failure manage-ment, from public health education and primary pre-vention to organ replacement therapies;

• Has relevance to low- and middle-income countries byemphasizing that successful implementation of efficientand effective interventions are possible in all contextswithout an unjustifiable distortion of existing publichealth priorities;

• Prioritizes the development of donation from deceasedpersons.

Reluctance to invoke the pursuit of self-sufficiency mayalso be due to a fear of creating impossible hope in promotingthe goal of meeting all needs for transplantation. However,although the achievement of self-sufficiency may currently bea remote goal in many societies, in others, there is evidence of

rapid and substantial progress. For example, in Norway, 70%of patients with end-stage kidney disease receive a kidneytransplant as their first line of treatment (http://www.nephro.no/nnr/AARSM2008.pdf). Regardless of the currentchallenges facing the pursuit of self-sufficiency in some coun-tries, the ultimate goal remains both desirable and relevant tothose suffering organ failure throughout the world and willinspire efforts that strive ever closer to its achievement.

The optimization of donation after death constitutes thefoundation of the pursuit of self-sufficiency. The potential ofpatients who die with viable and functional organs at the time ofdeath is sufficient to meet all transplant needs—if only all oppor-tunities for donation could be enabled. Crucially, all societiesmust begin by engaging as early as possible with the concept ofdeath in the context of respective social, religious, and culturalvalues and customs, so that public discussion and education canaddress concerns and promote the development of responsiblepolicies concerning donation after death. To maximize thetherapeutic potential of donation from deceased persons,such policies must recognize donation after death as ethi-cally proper, including the recovery of organs from boththose who have died as determined by neurologic criteria(DBD) and after the irreversible cessation of circulationand respiration (DCD). Although DCD is currently notperformed in all jurisdictions, it is ethically proper as thedead donor rule that organ recovery is not the cause ofdeath is affirmed by this donation pathway.

In the face of divisive market forces that invoke urgentneeds for transplantation as an imperative to legitimize organsales, the global community must take action and promote agreater level of community involvement in transplantationand donation activities. The tragic phenomenon of trans-plant tourism should be replaced by a united global effortto reframe the human experience of death as a potentialopportunity to participate in a vital communal endeavorthat saves lives.

Some countries already demonstrate significant prog-ress toward self-sufficiency. The success of the Spanish Modelof Organ Donation in achieving 20 years of sustained in-creases in rates of organ donation is internationally recog-nized, and Spain already has a comprehensive strategic planto further increase organ donation after death to a rate of 40donors per million population (3). Elsewhere, transplanta-tion laws prohibiting organ sales are being introduced, re-flecting a growing political resolve to end the practices oforgan trafficking and transplant tourism. The Madrid Reso-lution is a significant step toward a universal approach toorgan donation and transplantation and an internationalcommitment to the pursuit of self-sufficiency. Significantly,the Madrid Resolution also offers a roadmap of the way for-ward that has relevance in all contexts and can be adapted tolocal realities.

OFFICIAL OPENINGTrinidad Jimenez Garcıa-Herrera, Minister of Health

and Social Policy, Spain welcomes the attendees to the Ma-drid Conference on Organ Donation and Transplantationand gives the floor to participants for the official opening.

Isabel de la Mata, Public Health Advisor, European Com-mission recalls the previous Spanish Presidency of the EU, during


http://www.nephro.no/nnr/AARSM2008.pdf

http://www.nephro.no/nnr/AARSM2008.pdf


which a Conference on Tissues and Cells was held. Discussionsbegan laying the groundwork for the development of the Direc-tive and its subsequent approval. The debate about the Directiveon Quality and Safety Standards of Human Organs Intended forTransplantation and the Action Plan started back in 2008,thanks to the efforts of the European Commission and the MS.The Commission intends to find a balance between the require-ments for quality and safety of organs, tissues, and cells, andrecognition of the different organizational approaches in placein the EU. The Spanish Presidency will exert maximum efforts toget a first-reading agreement on this Directive in June 2010, andto see the maximum benefits for patients derived from this po-litical initiative, along with the Action Plan.

Steffen Groth, Director Essential, Health Technolo-gies, WHO refers to the 57th World Health Assembly Res-olution on Human Organ and Tissue Transplantation. As aconsequence of this Resolution, many countries have con-demned the commercialization of the human body andorgan trafficking. This trade is inconsistent with the mostbasic human values and contravenes the Universal Decla-ration of Human Rights and the spirit of the WHO Con-stitution. Although consensus is being built regarding theethical principles guiding organ donation and transplan-tation, the insufficient number of organs available to meettransplantation needs remains a challenge. Self-sufficiencyin transplantation is to be understood as a communityresponsibility. Every person could be a potential organrecipient, so every person should recognize him orherself as a potential organ donor after death. The WHOaim for this conference is making the concept of self-sufficiency possible.

Jeremy R. Chapman, President of TTS thanks the Span-ish Ministry of Health, the European Commission, the WHO,and Dr. Francis Delmonico from TTS for making this Con-ference possible and for their dedication, which are makingdonation and transplantation progress and bringing im-mense benefits for patients.

Jo Leinen, Chair of the Committee on the Environ-ment, Public Health and Food Safety, European Parliamentstresses the timeliness of the Conference, because the EU isimmersed in debate concerning the Directive on Qualityand Safety Standards of Human Organs Intended forTransplantation. There are wide variations between MS inrates of donation after death, and the shortage of organs isa major factor affecting transplantation programmes. TheCommittee of Environment, Public Health, and FoodSafety of the European Parliament has just voted on tworeports concerning the Directive, and the Action Plan, thelatter aiming to achieve a better cooperation between MSin the field. The Directive includes the principle of voluntary,unpaid donation and specifies measures for the protection ofthe living donor, issues of paramount importance for the Par-liament. Given the need to match donors with recipients, therelevance of cross-border exchange of organs is also to beemphasized.

Spain is a good example of success in significantly in-creasing the number of deceased organ donors. It has beenproven that such increase is linked to the introduction ofcertain organizational measures that enable the system toidentify potential donors and maximize their conversion intoactual donors. The role of public awareness and opinion in

increasing organ donation rates should also be recognized. Itis to be expected that this Conference brings us a step furthertoward an efficient, high-quality, organ donation and trans-plantation scheme for the whole EU.

Round Table Ministries of Health

Country Benefits of a Common European StrategyTrinidad Jimenez Garcıa-Herrera, Minister of Health and

Social Policy, Spain presents participants to this round table.Ana Marıa Teodoro Jorge, Minister of Health, Portugal

expresses the deep support of Portugal for a common Euro-pean strategy. Portugal has evolved from 19 donors per mil-lion population in 1996, to 31 donors per million populationin 2009. This improvement has been possible because of sev-eral different actions, including the introduction of trans-plant coordinators in ICUs and the training of professionalsin donation and transplantation. In this regard, the work car-ried out by the University of Barcelona and its TransplantProcurement Management Course is to be acknowledged,another example of the close cooperation between Spain andPortugal in the field of donation and transplantation overrecent years. Transplantation saves lives and improves thequality of life of patients, but the shortage of organs within theEU is a reality, and efforts are to be made for the pursuit of thisnew concept of self-sufficiency. In this regard, instrumentsfor the promotion of international cooperation are necessary,including those which allow an active exchange of organsbetween countries, while preserving the quality and safety ofthe organs transplanted.

Annette Widmann-Mauz, State Parliament Secretary,Germany stresses the fact that the number of patients on thewaiting list for a transplant far exceeds the number of donors.MS must work together to increase donation; hence, cooper-ation between MS is necessary. The Directive on Quality andSafety Standards of Human Organs Intended for Transplanta-tion of the European Parliament and of the Council foresees theestablishment of a network of MS competent authorities and setsdown the importance of organ exchange between countries, asactively performed by European organizations, in particular Eu-rotransplant or Scandiatransplant. The Directive also includesprovisions to ensure a uniform level of quality and safety of or-gans. At the same time, the Directive provides flexibility to MSwith regards to the details of transposition to national legislation.Germany is supportive of this Directive and particularly empha-sizes the importance of two articles: #13, relating to the voluntaryand unpaid nature of donation, two basic principles which alsohelp to guarantee the safety and quality of organs and #15, reg-ulating the protection of the living donors. The Directive willbring undisputed advantages for EU countries and immensebenefits for their patients.

Melinda Medgyaszai, State Secretary, Hungary un-derlines the danger of organ trafficking and the impor-tance of both initiatives, the Directive and the Action Plan,in contributing to the prevention of trafficking related totransplantation. The need to increase organ availability isalso essential, while respecting the quality and safety stan-dards of organs for transplantation, as provided for withinthe Directive. In this regard, the importance of everyone’ssolidarity is to be underlined.


Trinidad Jiménez García-Herrera Spanish Minister of Health and Social Policy

“Ministers, Parliamentarians, and Health Authorities from different countries from the five continents who have come to this Conference, from WHO, from the EU and from the Council of Europe, transplant professionals, coordinators and directors of the different transplantation organizations, members of TTS, dear friends from Latin America participants to the 6 Edition of the MASTER ALIANZA, members of the patients´ associations, dear friends all:

th

It is a pleasure for me to welcome you to this MADRID CONFERENCE ON ORGAN DONATION AND TRANSPLANTATION, organized by the Spanish Presidency of the EU and assembling relevant personalities from health-care administrations and the field of organ donation and transplantation from the five continents, which will make Madrid be considered the WORLD CAPITAL OF TRANSPLANTATION during the next three days.

The main objective for today´s meeting is very clear: to foster a decisive collaborative strategy on donation and transplantation among the MS of the EU, which should lead us to build the biggest structure of the world in this field, covering 500 million people with the highest standards of quality on one hand, and the highest quantity on the other in terms of access to these therapies on which so many lives depend.

With this purpose, already announced at the end of 2008, two initiatives of the European Commission are on the table for which the Spanish Presidency is giving maximum support. Above all, the support provided to the project of a European Directive on standards of quality and safety of human organs intended for transplantation is to be highlighted. The process is well advanced at the Council as well

As a perfect complement to the Directive, the Action Plan intends to promote cooperation on organ donation and transplantation among all MS. One single example can exemplify the importance of this collaboration: if rates of donation from deceased persons in the EU, currently at 18.1 donors per million population, reached those of countries with the highest performance, the lives of more than 20,000 people either with no chance at present of a vital organ transplant or otherwise condemned to chronic dialysis would be saved every year.

As you well know, Spain is very proud of its transplantation system, which allows our country to lead the world in the expression of solidarity that is organ donation. This has been possible since the beginning of the nineties, after the creation of the Spanish National Transplant Organization, ONT. Over the years since, we have developed a long experience of cooperation with other countries, either in a bilateral form with those requesting collaboration or through international organizations.

We have chaired the Commission of Transplantation of the Council of Europe for seven years, bringing about the development of most of the documents on which the current projects of the Commission are based. We believe that now is the time for the EU to implement these initiatives for cooperation, from which thousands of European citizens will benefit.

Yet the scarcity of organs for transplantation is a global problem, and any European strategy should be placed in a universal context. That is why this European Conference serves as an opening for a Global Consultation on donation and transplantation, organized with the WHO and TTS. The objectives are very clear: to progress in the pursuit of self-sufficiency in organ donation and to combat transplanttourism. I would like to give my warmest welcome to all the members of the different tourism. I would like to give my warmest welcome to all the members of the different entities, with my sincere wish for you to have fruitful work days among us and to go back to your countries with the best of impressions.

ONT is a WHO collaborative center, and its cooperative activities with countries from the five continents to promote organ donation are long-standing and have led to promising results. To provide an example, the case of Latin America should be mentioned. ONT, in close collaboration with the Pan American Health Organization, contributed to the creation of the Latin American Council on Donation andTransplantation five years ago. This entity has been decisive for the regulation and development of donation in all Latin American countries, with a very significant increase in organ donation rates of 20% in the past five years, and a training programme already delivered to more than 200 coordinators from Spanish and Portuguese speaking countries. About to finish the MASTER ALIANZA next Friday, some of the professionals trained as transplant coordinators in Spain are among us today.

as at the Parliament and we are sincerely hoping a first-reading agreement.

To summarize, I believe that these working days that are about to start are the culmination of the Spanish approach to international cooperation in the transplantation field and will become a point of reference in worldwide collaboration. It is necessary to provide global solutions to universal problems, and Spain is prepared to contribute with the best of its experience in this area through ONT. I assure you that no effort has been spared in this endeavor and that we will continue doing our best to save lives around the world thanks to the universal expression of solidarity that is organ donation and transplantation.

THE MADRID CONFERENCE ON ORGAN DONATION AND TRANSPLANTATION is open.”



Koenraad Vandewoude, Social Integration Responsible,Belgium refers to the Belgium Transplantation Law enacted in1986, which already established the principles of altruistic dona-tion and non-commercialization and provided for a presumedconsent policy. In Belgium, organ allocation is performedthrough Eurotransplant. Belgium welcomes the Commission’sproposal for a Directive on Quality and Safety Standards of Hu-man Organs Intended for Transplantation, especially those pro-visions related to the voluntary and unpaid nature of donation,the characterization of donors and organs, and the foreseen pos-sibility of building national registries for transplanted patients.All these elements are essential to ensure the quality of the organsand the safety of transplant recipients.

Janez Remskar, Transplant Coordinator, Sloveniastresses the importance of European and International coop-eration for Slovenia, a small country with a population of only2 million. The National Transplant Network was created in1998, including 10 procurement hospitals and a single trans-plant center; therefore, it was not possible for the country towork alone. Slovenia started to work with Eurotransplant in2000 and enacted its national Law on Donation and Trans-plantation that same year. A new law has been adopted in2010, under which the policy of presumed consent is estab-lished. It is expected that this new policy will be of benefit forpatients and their relatives, and will make easier the work ofprofessionals. Because of the immense benefits expected from thisEuropean initiative, Slovenia highly supports the upcoming Euro-pean Directive on Quality and Safety Standards of Human OrgansIntended for Transplantation.

Current Challenges in Organ Donation andTransplantation in the EUSession ChairsGunter KirsteDirector, Deutsche Stiftung Organtransplantation,GermanyEnrique MorenoHead of Department of General and Digestive Surgery,Hospital 12 de Octubre, Spain

Organ Shortages and Disparities in Access toTransplantation in EuropeRafael MatesanzDirector, ONT, Spain

Approximately 100,000 solid organ transplants are per-formed annually worldwide (of which almost 70,000 are kid-ney transplant procedures), providing excellent results interms of survival and quality of life. Acute and chronic rejec-tion of organs represents an important barrier in the devel-opment of transplantation services, which have been partiallyovercome with advances in immunosuppression. The mainobstacle to further development is a shortage of organs: datafrom both Europe and the United States show waiting listgrowth far outstripping growth in incident transplantationrates. In the EU, approximately 60,000 patients were on thewaiting list for a kidney, a liver, a heart, or a lung at the end of2008, whereas only approximately 25,000 procedures of thisnature were performed during that entire year. It is estimatedthat 12 EU patients die each day while waiting for an organ. Aprogressive increase in the demand for organs for transplan-tation, particularly for kidneys, is expected to occur in com-

ing years because of the epidemics of diabetes and arterialhypertension, along with the ageing of the population. A sec-ond significant challenge is ensuring the safety and quality ofthe organs available for transplantation. Risks are associatedwith the use of organs. Both infectious and neoplasic diseaseshave been transmitted from donors to recipients through thetransplantation of a solid organ. Risks may be minimizedwith an appropriate evaluation of the potential deceased or-gan donor.

The diversity of organ donation and transplantationactivities in the EU is highlighted by data collected by severalEU-funded projects and data consortia, in particular the Im-proving the Knowledge and Practices in Organ Donation(DOPKI) project (www.dopki.eu). Opting-in and opting-outconsent policies coexist in addition to variable organizationalapproaches. For example, not all EU countries have a NTO inplace, and several are part of supranational organ exchangeorganizations, as Eurotransplant and Scandiatransplant.There are huge disparities in activities in donation from de-ceased persons, with Spain, where the number of deceaseddonors evolved from 550 to 1600 over the years from 1989 to2009, as an international benchmark. The evolution of ratesof donation after death in Spain is not the result of theimplementation of what could be considered “classicalapproaches” in response to organ shortage, that is, promo-tional campaigns or registries of intention to donate. Nor is itbecause of a progressive swell of support from the populationtoward organ donation (a survey performed on a representa-tive sample of the Spanish population showed similarpercentages indicating support in 1993 vs. 1999 vs. 2006).Instead, the critical determinants of the success of the SpanishModel of Organ Donation have been the organizationalimprovements implemented: a coordination network, in-house transplant coordinators (mostly critical care physi-cians who assume the coordination role on a part-timebasis), ONT as a support agency, a continuous brain deathaudit, training of healthcare professionals, close engage-ment with the media, and reimbursement of procurementactivities.

Variation in mortality rates attributable to trafficaccidents and cerebrovascular diseases in the EU do not ap-parently justify the regional differences in donation from de-ceased persons nor is there evidence of a correlation betweenthe proportions of people who report that they would belikely to donate their organs after death and achieved ratesof donation from deceased persons (http://ec.europa.eu/public_opinion/archives/ebs/ebs_272d_en.pdf), suggestingthat a positive public attitude toward donation is not the ma-jor determinant of success. In EU countries where increasingrates of donation after death are being achieved, many ofthese donations are coming from aged donors in the 60� and70� age categories, less frequently considered as potentialdonors in other countries. Another factor influencing dispar-ities in deceased donation activity in the EU is the significantvariation in uptake of DCD, with DCD not permitted by lawin several jurisdictions, whereas in others, the necessary ex-pertise is not available. In the United States, observed in-creases in organ donation rates evident since 2003 have af-fected both DBD and DCD. In contrast, rates of donationfrom deceased persons have stabilized in the EU during thesame period of time, with the implication that this is in part


www.dopki.eu

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http://ec.europa.eu/public opinion/archives/ebs/ebs 272d en.pdf

because of a lack of uptake of DCD in the region. Moreover,other specific strategies such as the United States Organ Do-nation Breakthrough Collaborative have helped the US prog-ress in improving rates of donation from deceased persons inrecent years.

The work carried out by the Council of Europe in theEuropean setting is to be recognized, with more than 14 rec-ommendations produced, along with an excellent informa-tive tool on donation and transplantation activities andwaiting list data: the Newsletter Transplant (available at:http://www.ont.es/publicaciones/Paginas/Publicaciones.aspx).These recommendations, in particular the European ConsensusDocument entitled “Meeting the Organ Shortage” have inspiredthe draft European Directive on Quality and Safety Standards ofHuman Organs Intended for Transplantation and the ActionPlan. Intraregional European partnerships have also producedsuccessful outcomes, for example, the cooperation between Italyand the Slovak Republic. Although extensive efforts for harmo-nization in Europe have been made, there is still a long way to go.The upcoming Directive and the Action Plan represent an excel-lent opportunity to move to a new EU situation where rates ofdonation from deceased persons evolve to the levels of theSouthern countries, and rates of donation from living persons tothose of Northern countries, while respecting the ethical frame-work laid out in the WHO Guiding Principles for Human Cell,Tissue and Organ Transplantation. Through the establishmentof common standards of quality and safety for EU countries, it isalso expected that the exchange of organs between MS will befacilitated, both better serving the needs of patients with partic-ular transplantation needs and simultaneously avoiding the lossof organs not to be used locally for different reasons, that is, thelack of a specific transplantation programme.

Safety and Quality Systems in Organ Transplantation inEuropeAlessandro Nanni CostaDirector, Centro Nazionale Trapianti, Italy

Although safety and quality systems in transplantationhave been recommended over the years, standards in this re-gard are highly variable among European countries. A com-prehensive approach to safety and quality in organ donationand transplantation must extend from the moment of donoridentification through to the follow-up of recipients, andcover all clinical, logistical, and decision-making aspects ofthe donation and transplantation process. This comprehen-sive approach should include:

• Donor management: identification, diagnosis, referral,first assessment, maintenance, family interview, recipi-ent selection, organ recovery, second assessment, trans-plant, and follow-up;

• Pretransplant recipient management: diagnosis, indicationfor transplantation, clinical and immunologic assessment,inclusion in the waiting list, admission and treatment, pe-riodic testing, selection for transplantation, summoning,preparation, transplant, and follow-up;

• Transplanted patient management.

In donor management, timing is a critical factor in-fluencing quality, and its optimization relies on decentral-ized assessment and diagnostics. Thus, donor assessment

must be understood as a dynamic process, with risk levelsassessed before recovery (through medical history, exter-nal examination, biochemical, serologic, and tool tests),confirmed or modified during recovery (through histol-ogy, biomolecular tests, palpation, and inspection), andreassessed during transplantation (through back-tablesurgery and autopsy).

In pretransplant recipient management, the criticalissues in quality of care are the provision of dishomoge-neous information to patients, inadequate or poor infor-mation on possible therapeutic options, different criteriafor screening and admission, different composition andmanagement of waiting list, and dishomogeneous or non-transparent allocation criteria. Consequences are confu-sion, comparison with other experiences, preclusion ofchoices, conditioning of healthcare pathway, patientsmoving from one transplantation center to the other, per-ception of inequalities whether justified or not, and highvariation of waiting list satisfaction indexes, and risk ofethics violations and a lack of system transparency.

The management of the transplanted patient is the start ofa new process, with two important factors influencing its quality:the failure to identify the person responsible for follow-up (re-sulting in the consequences of a discontinuous physician-patientrelationship, possible “differences” in follow-up approach anddifficulty in operational coordination between general practitio-ner and specialist), and the alternation of interlocutors (withbehavioral differences in prescriptions and patient health care,possible duplication of physician interventions, and nonperson-alized management of follow-up).

Results of the DG SANCO survey on quality and safetyof organs for transplantation were presented at the VeniceConference in 2003. No specific legal or technical provisionregulated the traceability (14%), procurement (46.4%) andtransplantation (32.1%) centers, and the storage of serumsamples (32.1%) of a significant percentage of EU countries.In addition, risk assessment guidelines vary from country tocountry, and there is a need for clear protocols concerning theutilization of organs from donors with conditions such asneoplasia or history of tumor, positive viral markers for HCVand HBV, known risky behaviors for viral infections oremerging infectious diseases, among others (4). Protocols arealso generally absent concerning upper age limits for donors.The evaluation of the acceptability of an organ is not absolutebut is relative to the specific donor risk factor(s) in questionand the type of organ(s) being evaluated. The complexity ofthis evaluation process gives rise to situations that are notalways foreseeable and cannot be captured in a referenceguide. Therefore, the transplantation process needs the sup-port of on-call infectious disease specialists for accurate andadequate risk assessment. Ultimately, transplantation of or-gans from a high-risk donor cannot be justified in nonlife-threatening circumstances.

Communication of the European Commission: PolicyOptions and Impact AssessmentIsabel de la MataPrincipal Advisor in Public Health, DG Health & Consumers,European Commission

Action of the EU in the field of human organs intendedfor transplantation are based on the power conferred through


http://www.ont.es/publicaciones/Paginas/Publicaciones.aspx


article 168 (a) of the Lisbon Treaty, which allows theUnion to establish: “Measures setting high standards ofquality and safety of organs and substances of human ori-gin, blood, and blood derivatives; these measures shall notprevent any MS from maintaining or introducing morestringent protective measures.”

Any legislative process in the EU has the following steps:

• Problem identification;• Open consultation;• Impact assessment;• Commission proposal;• Co-decision procedure: Council & European

Parliament.

In 2004, the Commission issued the following statement:“The important differences between organ transplantation andthe use of other human substances such as blood, tissues, andcells mean that a specific approach for organs to ensure safetyand quality is necessary. Such an approach in the currentsituation characterized by shortage of organs has to bal-ance two factors: the need for organs’ transplantation,which is usually a matter of life and death, with the need toensure high standards of quality and safety. The Commis-sion believes that before considering any proposal, it isnecessary to conduct a thorough scientific evaluation ofthe situation regarding organ transplantation. The Com-mission will present a report on the conclusions of theanalysis it undertakes as soon as possible.”

In 2006, an Open Consultation was held with expert par-ticipation from MS, NTOs, Members of the European Parlia-ment, the Pharmaceutical Industry, Patient Associations, andMedical and Surgical Associations. In 2007, the Commissionpublished the document “Communication on Organ Donationand Transplantation: Policy Actions at EU Level.” From thispoint forward, the European Commission, together with theMS, commenced work on legislation in this field. The open con-sultation allowed current problems and challenges in the field ofdonation and transplantation in the EU to be defined. Severalpolicy options were weighed-up to confront the predefinedproblems, along with an assessment of the clinical and economicimpacts of each of these options. From this in-depth analysis, thefinal best option consisted of (1) an Action Plan for MS to workon from 2009 to 2015; and (2) a flexible Directive on Quality andSafety Standards of Human Organs Intended for Transplanta-tion, for which approval is foreseen to occur under the SpanishPresidency of the Council of the EU (January to June 2010).

The Action Plan identifies 10 priority actions, which aregrouped under three challenges: to increase organ availability,make transplantation systems more efficient and accessible, andimprove quality and safety in the donation and transplantationprocess. The priority actions are as follows:

1. Promote the role of donor transplant coordinators in ev-ery hospital where there is a potential for organ donation.

2. Promote quality improvement programme in every hos-pital where there is a potential for organ donation.

3. Exchange of best practices in programmes for the do-nation of organs from living persons among EU MS.Support registers of living donors.

4. Improve the knowledge and communication skills ofhealth professionals and patient support groups on or-gan transplantation.

5. Facilitate the identification of organ donors across Eu-rope and cross-border donation in Europe.

6. Enhance the organizational models of organ donationand transplantation in the EU MS.

7. Promote EU-wide agreements on various aspects oftransplantation medicine.

8. Facilitate the interchange of organs between nationalauthorities.

9. Evaluation of post-transplant results.10. Promote a common accreditation system for organ do-

nation/procurement and transplantation programmes.

The Directive intends to set down minimum qualityand safety requirements of human organs intended for trans-plantation for EU MS. It excludes blood and blood compo-nents, tissues, and cells and organs of animal origin, and itcovers the donation, procurement, testing, preservation,transport, and transplantation of organs. Main elements ofthe Directive are: the establishment of authority or author-ities for national oversight, the authorization of procure-ment and transplantation activities, the establishment ofNational Quality Programs, ensuring the traceability oforgans, the reporting of serious adverse events and reac-tions, the protection of the living donor, and ensuring acomplete characterization of the donor and organ(s) toenable the transplant team to undertake an appropriateand individual risk assessment.

The Initiatives of the EU in the Field of OrganDonation and TransplantationSession ChairsArie OosterleeDirector, Eurotransplant International Foundation (EIF)Jean-Marc SpieserHead of Department of Biological StandardizationEuropean Directorate for the Quality of Medicines & Health-Care, Council of Europe

European Legislative Framework on Quality and SafetyAspects of Organ Donation and Transplantation: TheEuropean DirectiveMiroslav MikolásikMember of the European Parliament

The regulatory approach of this proposed Directive basedon a framework model ensures that legislation is laid down todeal with key aspects of organ donation and transplantation,while not prescribing detailed policy measures that are the pre-rogative of MS. The Directive will ensure that the necessary qual-ity and safety structures are in place, facilitating the conditions

‘The intended increase in the number of donors and available organs for transplantation cannot be achieved at any price’ (DOPKI Newsletter 2009, available at: http://www.dopki.eu/Newsletter2009.pdf)


for organ exchange and ensuring high standards of quality andsafety for all patients in Europe. The Directive, given its bindingnature, will support and trigger the implementation of key pri-ority actions of the Action Plan.

The specific issues that have provoked particular inter-est during Parliamentary debate, giving rise to a set of pro-posed amendments in the Parliament report, are as follows:

1. Voluntary and unpaid donation: when the act of donationis not voluntary or foresees financial gain, the quality of thedonation process can be jeopardized, because improvingthe quality of life or saving the life of a person is not themain, and the unique objective to be achieved. Hence,these are core principles in this new legislative framework.

2. Protection of living donor: information provided to and bythedonorwithregardstodonationandaproperevaluationofthe donor are essential to minimize the risks for both donorsandrecipients.Reimbursementtothe livingdonorhasbeenasubject of debate in the Parliament, with a specific proposal

for limiting that reimbursement to “making good the ex-penses and inconveniences related to donation.” Conditionsfor such reimbursement would be then established by MS.

3. Data protection: the implementation of the proposedorgan donation and transplantation scheme requiresthe processing of personal data relating to health of theorgans, donors, and recipients by authorized organiza-tions and healthcare professionals of the different MS.These data are deemed sensitive and fall under the strictrules of data protection on special categories of data.

4. Donation from living persons: to ensure that the principlesof voluntary and unpaid donation are maintained, someissues regarding donation from living persons have raisedconcerns at the Parliament. Not aiming at limiting do-nation from living persons who are not close relatives,the Parliament would like to make clear the need tocarefully examine and confirm the absolute altruisticnature of donation under these circumstances.

Box 1

The European Directive and The Action Plan: Key Points

The European Directive

• The Directive is primarily concerned with ensuring a high level of human health protection throughout the EU by establishingcommon minimum standards of quality and safety of human organs intended for transplantation.

• The Directive will establish the obligation of MS to designate one (or more than one) competent authority responsible for theimplementation of the provisions set down in this Directive. A network of competent authorities will be subsequently coordinatedby the European Commission, laying the grounds for the biggest organization related to donation and transplantation worldwideand covering a population of about 500 million people.

• The need to create a quality and safety framework, including transparent procedures for the adequate development of the processof donation and transplantation is set down in the Directive, along with the capability of control or auditing the activities. MS willalso be required to establish systems for the authorization of organ procurement and transplantation, and specific requirements will be set down for the exchange of organs with third countries.

• A system for reporting serious adverse events and reactions is to be developed by every MS, which should also assure a system fortraceability, while respecting confidentiality and data protection rules.

• The respect for principles consistently supported over the years by the WHO, the Council of Europe, and the EU is to be maintained. Donation is to be a voluntary and unpaid act, and the protection of the live donor is to be ensured. These principlesimply the respect for fundamental human values but are also essential to not jeopardize the safety and quality of the process ofdonation and transplantation, the legal basis under which the Directive is built.

• The debate on the Directive is now being held, with such issues raised from the perspective of citizens, patients, and professionalas the establishment of limits to donation from living persons, the inclusion of technical aspects in the legal text, and theconsideration of a mandatory post-transplant follow-up registry.

• After its approval, MS will have 2 years to transpose the Directive into their national law. Along with the pursuit of increasedquality and safety of organs for transplantation, benefits expected include the facilitation of organ exchange between MS and thecreation of an effective system to combat organ trafficking.

The Action Plan

• The Directive is supported and complemented by the Action Plan on organ donation. The Action Plan sets out common objectives,agreed quantitative, and qualitative indicators for monitoring performance and benchmarking strategies, protocols for regularreporting, and identification of best practices, with the goal of increasing the number of organs available for transplantation.

• The Action Plan will promote a number of initiatives aimed at increasing organ donation through organizational changes thathave proven effective in some MS(i.e., promoting the figure of the transplant coordinator or implementing quality assurance programmes in the deceased donation process). It will also help MS to evaluate the performance of their transplant systems andexchange best practices to improve them.



5. Death certification and consent: two additional amend-ments are worth mention: (1) “MS shall ensure thatorgans are not removed from a deceased person unlessthat person has been certified dead in accordance withnational law”; and (2) “No organ removal may be car-ried out on a person who under national law does nothave the capacity to consent it.”

The Action Plan: Promoting the Cooperation Between EUMember StatesAndres PerelloMember of the European Parliament

The main motivation for the implementation of an Ac-tion Plan on organ donation is the need to increase the rate oftransplantation overall and to reduce the disparities in therates of donation and transplantation among EU MS,through cooperation and sharing of best practices. The Ac-tion Plan is developed in parallel to the Directive on Quality

and Safety Standards of Human Organs Intended for Trans-plantation. The report prepared by the Parliament on theAction Plan stresses once again the principle of voluntary andunpaid donation and demands MS put in place punitive mea-sures against organ trafficking. It also opens discussionsabout donation from living persons and welcomes the estab-lishment of rules of quality and safety for all MS.

The Proposal for a Directive on Standards of Qualityand Safety of Human Organs Intended for Transplantationwas voted in the Environment, Public Health and Food SafetyCommission of the European Parliament on the May 16, 2009,and the result was a unanimous vote in favor. The spirit of theParliament suggests a first-reading agreement on next May 2010.

Consistency in the debate concerning the key aspects ofthe Directive and the Action Plan should be maintained in theParliament. Because donation from living persons, developedunder solid ethical principles, is a necessary component of strat-egies to confront organ shortages, restrictions to donation from

Box 1 cont.

Challenges for the European Union in organ donation and transplantation

• The shortage of organs to cover the transplantation needs of the population is a European and a universal challenge. The disparity between supply and demand for organs means that many patients die or deteriorate whilst waiting for an organ, with an estimated 12 patients dying on the waiting list each day in the EU. As a result, a minority of patients are induced to seek alternative solutions outside of recognized ethical principles, usually in the form of transplant tourism.

• Although belonging to a common context, EU MS exhibit important differences in donation and transplantation activities. Variability in rates of donation after death between EU MS is not seemingly due to differences in mortality rates or in the public support to organ donation. On the contrary, differences in the organizational approach to donation from deceased persons might be the underlying reason for this variation. Donation from living persons also shows a different level of development between European countries.

• Specific types of organ transplantation, such as the heart or lung, are not performed consistently across Europe. In many instances, there is a significant scope to improve the number of organs recovered per donor, although for some countries a lack of the necessary expertise to support cardiothoracic transplantation is the barrier to the expansion of heart or lung donation and other transplantation programmes.

• Europe demonstrates several examples of multinational ambition and corporation in organ donation and transplantation. However, with greater interregional cooperation and greater exchange of organs across borders, there is an emerging need for common safety and quality standards in transplantation at the EU level. On their own, these common standards could foster crossborder exchange of organs, which would increase the chances of transplantation for patients with very particular needs (pediatric, highly sensitized, and urgencies), and provide the opportunity of using surplus organs (because of the lack of an appropriate recipient or that of a specific transplant programme locally).

• A review of current knowledge and recommendations for quality and safety practices in organ donation and transplantation is needed, followed by an evidence-based update of these recommendations that develops clear protocols concerning the utilization of organs from donors with risk-related conditions or behaviors.

• Better risk prediction is urgently needed concerning the outcomes of transplants from expanded criteria donors and nonstandard risk donors. This would be facilitated by international coordination of monitoring and surveillance data from organ donation and transplant registries, and universal best practice in data registration. European cooperation would be enhanced by the formation ofa Europe-wide registry of organ donation and transplantation policy, practice, and outcomes similar to the UNOS/SRTR.

• Efforts for harmonization, both in terms of donation and transplantation activities and in terms of quality and safety between European countries, have been pursued by the Council of Europe for years, and by the EU, through dedicated collaborative actions.However, there is still a challenging scenario where much remains to be done.

• In the diverse landscape just described and after a period of consultation and evaluation of different policy options, the European Commission intends to promote two complementary initiatives: a common legal framework to ensure common quality and safetystandards for human organs intended for transplantation (the Directive) and an Action Plan integrating different actions targeted not only to ensure quality and safety but also to increase organ availability and to make the transplantation systems more efficientand accessible.


living persons in the EU that are currently being consideredcould potentially inflate problems with respect to organ traffick-ing and transplant tourism. Desperate patients may be driven tosearch for alternatives outside of the legal and ethical frameworkthat we pursue. The Action Plan should aim to increase donationrates in the EU while fostering solidarity as the way to avoidviolations of fundamental human values.

The Patient’s PerspectiveTerence P. ManganChairman, European Heart Lung Transplant Federation,Ireland

Differences in donation and transplantation activities,most particularly for thoracic organs, become evident in theanalysis of available data in Europe, even when comparingcountries with a similar capacity to perform transplantation.Heart and lung transplantation activities are highly variableand differently developed between countries even with simi-lar overall rates of donation after death. In many instances,there is significant scope to improve the number of organsrecovered and transplanted per donor, although for somecountries there is a lack of the necessary expertise to supportcardiothoracic transplantation. Refusals to consent to organdonation after death are a key factor in the variation in dona-tion and transplantation rates in Europe. In this context, theimportance of the European Donation Day to raise awarenessof the importance of organ donation after death among the gen-eral public is to be highlighted. However, there also needs to be afocus on the way the approach to organ donation is made, that is,who asks, what to say, how to say it, and when to say it. The pillarsof our activities should be the equal access to high quality trans-plant services in MS, the professional and timely post-transplantcare, and maintenance and the right to appropriate post-trans-plant immunosuppressive drugs and medication.

Alejandro ToledoPresident, Federacion Nacional de Asociaciones para la Luchacontra las Enfermedades Renales, Federadción Nacional deAsociaciones para la Lucha contra las Enfermedades Renales(ALCER), Spain

During the 1970’s, end-stage kidney failure patientswere able to survive on the basis of reasonably widespreadaccess to dialysis. Organ donation and transplantation didnot have a legal basis yet in Spain, and the public knowledge ofthis option was scarce. ALCER was created in 1976 andstrongly supported the development of a Transplant Law inSpain during the period 1977 to 1978. Our Transplant Lawwas finally enacted in 1979.

During the 1980’s, organ donation remained scarce, andthe patients’ association put pressure on society and politicians.It was the time to consider the need for a National CoordinatingOrganization. It was in 1989 that, in response to this pressure,ONT was created. The need for a NTO has been put forwardinternationally as a basic element for a deceased donationsystem to be effectively established and consolidated.ALCER continues acting in support of donation and trans-plantation through many activities, making evident the ex-tent to which patient associations are stakeholders with aspecific contribution to make to the pursuit of self- suffi-ciency in transplantation. ALCER is now engaged in activ-ities such as the provision of information to patients andtheir relatives about donation from living persons, and inupdating patients about initiatives that may help them toimprove their quality of life and life expectancy.

Transplant Professionals’ PerspectiveFerdinand MuehlbacherHead, Division of Transplant, Medical University of Vienna-Austria

Three European Regulatory bodies in the field of dona-tion and transplantation currently coexist: (1) the Council ofEurope (47 MS) that has produced several recommendations;(2) the EU (27 MS), acting on the basis of article 168�a� of theLisbon Treaty (previous 152a of the Amsterdam Treaty), nowreleasing the Directive and the Action Plan; and (3) NationalGovernments producing the corresponding national legisla-tion. The Council of Europe has been working on issues ofsafety and quality of transplantation for several years and hasproduced a guide to safety and quality assurance for organs, tis-sues and cells containing information on basic principles forquality management, selection of donors, organ procurementand preservation, tissue and cell procurement, tissue establish-ments, and transplantation practices (http://www.coe.int/t/dg3/health/Source/GuideSecurity2_en.pdf). The last editionincluded an addendum on “Criteria for preventing the trans-mission of neoplastic diseases in organ donation.” This guideis a reference document for European countries.

Donation and transplantation, whether of organs, tissues,or cells, is not without some risk for the living donor, the recip-ient, and the healthcare professionals involved. Donor risks canbe broadly categorized into those relating to the function of thetransplanted organ and those concerning the transmission ofdiseases (tumor, viral, or bacterial infections or metabolic disor-ders). Donor risk factors relating to organ function are age, race,height, body mass index, cause of death [cerebrovascular acci-dent (CVA) and trauma], DBD vs. DCD (controlled vs. uncon-trolled), typeofgraft(fullsize,split,andreducedsize),coldischemiatime, steatosis, inotropic support, electrolytes (natremia), local re-covery, histology grading, laboratory data, and surgical judgment.Several issuesarestillunderdebate.Anti-HCV,anti-hepatitisBcoreantigen, and hepatitis B surface antigen prevalence varies according

Reflection

You are the warm sun on my face The gentle wind on my back You are the song in my heart

The music in my soul You are the promise of spring

And the glory of autumn You are my future

And my past You are my Donor And I am humbled


http://www.coe.int/t/dg3/health/Source/GuideSecurity2 en.pdf

http://www.coe.int/t/dg3/health/Source/GuideSecurity2 en.pdf


to the presence or absence of risk behavior, according to the Centerfor Disease Control and Prevention, Atlanta, USA (CDC) (5). Thereductionoftheso-calledwindowperiodispossiblethroughtheuseof the nucleic acid tests. However, currently, there is no sufficientevidence to recommend the universal prospective screening of or-gan donors for HIV, HCV, and HBV by nucleic acid tests.

Donor-derived diseases have also been a subject of re-search. Through a dedicated initiative, the United Networkfor Organ Sharing (UNOS) recorded information on donor-derived diseases in organ transplantation, recently publishedfor the years 2005 to 2007 (6). Both infections and malignan-cies were reported as having been transmitted.

The EU Directive on Quality and Safety Standards of Hu-man Organs Intended for Transplantation and the Action Planare focused on increasing the availability of organs, developingmore efficient and accessible transplant systems, and improvingthe quality and safety of the organs transplanted. However, threeoutstanding issues are identified, from the professionals’ point ofview, as not being adequately addressed by the Directive in itscurrent form. These are:

1. The concept of self-sufficiency, and a requirement forMS to do their utmost to improve organ donation,should be covered at least be in the preamble.

2. Although safety and quality measures are considered in theCommission proposal, no medical details should appearin a law. On the contrary, the current annex should makereference to “the best medical practice,” with recommen-dations produced every 2 years by a scientific-based body(i.e., Council of Europe CD-P-TO, ESOT, or a specific Ex-pert Group at the Commission).

3. A European Registry for the surveillance of donors andrecipients is essential to monitor and evaluate qualityoutcomes. Although a follow-up registry for the livingdonor is foreseen in the Directive, there is no specificprovision for the follow-up of transplant recipients. Aregistry similar to the UNOS/Scientific Registry ofTransplant Recipients (SRTR) database in the UnitedStates should be a goal for Europe. Currently, we arelimited to extracting conclusions from the US registrywhile acknowledging the expected differences betweenthe US and the EU populations.

These gaps in the Directive present future challengesfor the EU and should be the subject of ongoing improve-ments to this framework.

The Pursuit of Self-Sufficiency: A GlobalChallengeSession ChairsPeter DoyleIndependent Medical Advisor, United KingdomCarl-Gustav GrothProfessor Emeritus, Karolinska Institute, Sweden

Donation and Transplantation in the WHO AgendaLuc NoelCoordinator, Clinical Procedures, Essential Health Technolo-gies, WHO

Rapid medical advancements and the demonstratedsuccess of transplantation procedures have significantly in-

creased demand for human organs, tissues, and cells. Despiteconsiderable achievements in donation, demand continues tooutstrip supply, especially with respect to solid organs fortransplantation. Approximately 100,000 organs are trans-planted globally each year, however, given an estimatedburden of end-stage organ disease affecting upward of onemillion individuals, this accounts for less than 10% of globalneed (7). The 90% of people with end-stage organ failure whodo not have hope of a transplant will die from their disease or,in the case of end-stage kidney failure, be dependent on on-going and costly dialysis therapy. In many regions of theworld, affected persons lack access to basic healthcare ser-vices in which their need for transplantation would be rec-ognized, let alone met. For those who hope to receive atransplant, the implications of the scarcity of human ma-terials for transplantation are that: (1) individuals in needmay not be registered on transplant waiting lists, becauseinclusion criteria are influenced by the availability of or-gans for transplantation; (2) wait-listed persons may diewhile awaiting transplantation; and (3) some individuals,facing desperate situations, may seek to obtain an organ byengaging in practices such as transplant tourism, organtrafficking, or transplant commercialism.

These unethical practices exploit the poorest and mostvulnerable groups in society, undermine altruistic donation,compound socioeconomic disparities in the utilization of trans-plantation, violate the most basic of human values, contravenethe Universal Declaration of Human Rights, and have been re-pudiated by international institutions and professional societies.The global shortage of organs, tissues, and cells for transplanta-tion must therefore be met by strongly regulated environmentsto ensure safety, quality, efficacy, and ethical practice in all as-pects of organ donation and transplantation programmes.Health authorities should promote donation and transplanta-tion motivated by the needs of recipients and the benefits tothe community, and any measures to encourage donationshould respect the rights of donors and foster social recogni-tion of the altruistic nature of donation. These issues havebeen the subject of successive WHO Resolutions concerningorgan donation and transplantation (WHA 40.13/1987;WHA 42.20/1989; WHA 44.25/1991; WHA 57.18/2004).

Since their adoption by the WHA nearly 20 years ago,the WHO Guiding Principles for Human Cell, Tissue andOrgan Transplantation have played an important role in in-fluencing legislation, national policies, and professionalcodes and practices in the donation and transplantation ofhuman organs (WHA44.25). These Principles are concernedwith maximizing the benefits of transplantation by address-ing the needs of recipients, protecting donors and recipientsat all stages of the organ donation and transplantation pro-cess, and ensuring the dignity of all involved. In response toimprovements in transplantation medicine and science, andevolving practices and perceptions regarding organ and tissuetransplantation, a consultative process was commenced in2004 to update these Principles. Proposed revisions were thesubject of a global consultation held in Geneva in October2007. Revised Guiding Principles, reformulated to coverpractices identified since the original resolution was adoptedin 1991, were endorsed by the 124 Executive Boards of theWHO in January 2009 (Document EB124/15). The revisedPrinciples articulate a strengthened commitment to the


safety, quality, and efficacy of donation and transplantationprocedures and the human materials used, and request trans-parency in the organization and performance of donationand transplantation activities. They call for prohibition ofcommercialization of cells, tissues, and organs for transplan-tation and pay particular attention to the protection of vul-nerable populations. The priorities of the Principles are toprotect living donors, patients, individuals, and society,to foster public trust in transplantation and donation and tocombat organ trafficking. The WHO Guiding Principles forHuman Cell, Tissue, and Organ Transplantation thereforeencourage proper respect for human body parts and theirdonors, and for the patients receiving donated cells, tissuesand organs, and provide a framework for the development offair and equitable transplant services.

Global commitment to the WHO Guiding Principlesand to the eradication of the international trade in humantissues and organs is gathering momentum. China, Pakistan,the Philippines, Colombia, and Egypt, countries which weremajor destinations for transplant tourism, have each begun tointroduce transplantation legislation prohibiting organ sales.China implemented the State Council Law on Human OrganTransplantation in May 2007, which prohibits financial com-pensation for donors, prioritizes transplantation for Chinesecitizens over foreign nationals, and articulates consent pro-cesses and donor rights (8). This legislation also establishesminimal requirements that medical institutions must fulfillto be approved to perform transplantation. Transplant tour-ism in China has been markedly reduced since the introduc-tion of this legislation, and China is now seeking to formulatelegislation concerning brain death, to support the develop-ment of ethical organ donation from deceased persons.The Philippines introduced a Presidential ban on ForeignerTransplantation in April 2008, and The Philippine Society ofNephrology report that access to commercial kidney transplan-tation by foreign nationals has been significantly reduced (9). In2009, Colombia introduced a Resolution prohibiting transplan-tation to foreigners while Colombian patients remain on thewaiting list. In March 2010, Egypt passed a transplantation lawbanning organ trafficking, restricting donation from living per-sons to family members, and permitting regulated donationfrom deceased persons. Also in March 2010, Pakistan signed intolaw the Ordinance on Human Cell and Tissue Transplantation,prohibiting the sale of organs and providing for organ donationafter death.

These efforts are strongly supported by the WHO andby professional societies. In May 2008, an international meet-ing of representatives of scientific and medical bodies, gov-ernment officials, social scientists, and ethicists, convened byTTS and ISN, produced the Declaration of Istanbul on OrganTrafficking and Transplant Tourism (1). The Declaration ofIstanbul urges every country to implement legal and profes-sional frameworks governing the recovery of organs from de-ceased and living donors and the practice of transplantationthat are consistent with international standards of transplan-tation policy and practice. The Declaration also calls for thetransparent regulatory oversight of organ donation andtransplantation practices, intended to ensure donor and re-cipient safety, enforcement of standards, and the prohibitionof unethical practices. As organ sales, transplant tourism, andtrafficking in organ donors are largely an undesirable conse-

quence of the global shortage of human materials for trans-plantation, concomitant with the need for effective legalframeworks and regulatory systems is the need to increasesufficiency in the supply of organs, tissues, and cells for trans-plantation. Thus, the Declaration of Istanbul states that “Ju-risdictions, countries, and regions should strive to achieveself-sufficiency in organ donation by providing a sufficientnumber of organs for residents in need from within the coun-try or through regional cooperation.”

Wide international variation in transplantation activity(Figs. 3 and 4) not only reflects vast global inequity in accessto transplantation but also demonstrates the capacity of dif-ferent approaches to the delivery of organ donation andtransplantation programmes to produce better outcomes.For most high-income countries, current models of servicedelivery have not met the needs of patients, and there is scopefor significant progress in the provision of transplantation.The high prevalence of chronic diseases contributing to end-stage organ failure such as chronic kidney disease, estimatedto affect 10% to 15% of adult populations (10 –13), and theglobal epidemic of diabetes (14) underscore the need for ac-tion. There are also compelling economic arguments for self-sufficiency, taking the example of Japan where approximatelyUS $15 billion is now spent annually on providing treatmentto more than a quarter of a million individuals requiringmaintenance hemodialysis (15).

In addition to disparities in transplantation activity, ex-tensive international variation in the relative proportion ofdeceased vs. living donors is also apparent (Fig. 4), demon-strating widespread underutilization of the resource of de-ceased donor organs. Unrelenting growth of unmet demandfor transplantation, and a perceived inability to successfullydevelop deceased donation, have led to a trend toward invok-ing payment as the easiest approach to a greater supply ofhuman materials and proposals of market-based solutions,which rely on deceased or living donors sourced from domes-tic, or from foreign, populations. Such proposals present agrowing challenge to the basic principles of equality of humanbeings and integrity of the human body.

Responding to the need for action, a global network ofhealth authorities, scientific and professional societies, and ex-perts, drawn from every region of the globe and level of develop-ment, has formed with the support of the WHO and is workingto advance a common global attitude to transplantation andmodels of service provision that can meet recipient needs whilepreserving the dignity of donors. A comprehensive frameworkfor policy and practice directed at the global challenge of satisfy-ing organ donation and transplantation needs, consistent withthe WHO Guiding Principles for Human Cell, Tissue and OrganTransplantation, was developed by this network through a con-sultative process. The extensive recommendations of participantworking groups are given in full in Part II of this report.

Self-Sufficiency as a New Paradigm: Definition andSignificanceLuc NoelCoordinator, Clinical Procedures, Essential Health Technolo-gies, WHODominique MartinCentre for Applied Philosophy and Public Ethics, The Uni-versity of Melbourne, Australia



Self-sufficiency in organ donation and transplantationmeans equitably meeting the transplantation needs of a givenpopulation, using resources from within that population. Al-though each country will strive to develop a sufficient supplyof cells, tissues, and organs from donors within that country,regional cooperation may be necessary to effectively use all

donations and to address the most urgent needs of patients.Therefore, self-sufficiency may be pursued at an individualcountry level or through mutually beneficial regional organexchange networks and international collaborative efforts(16). The concept of pursuing self-sufficiency is founded inconcerns for equity in access to health care, transparent justice

FIGURE 3. Global transplantation activity in 2008. Map shows solid organs transplanted per million population. Datafrom (7).

FIGURE 4. Transplanted organs per million population in 2008, for the 50 most active countries globally. Data are takenfrom (7).


in the distribution of burdens and benefits of transplantationand donation, solidarity in the recognition of a common goaland responsibilities, and respect for the human right tohealth and dignity. The pursuit of self-sufficiency is a multifac-eted enterprise that has four main objectives: effective commit-ment from governments, community involvement, preventionof end-stage organ failure, and the identification and utilizationof all possible deceased donors.

The pursuit of self-sufficiency is a national responsibil-ity and begins at a jurisdictional level. The active commit-ment of government is required to produce the legislativeframework necessary to combat unethical practices, allow de-ceased donation programmes to grow, promote equity, anduphold the importance of organ donation in the community.Governments also have a critical role in the authorization andoversight of organ donation and transplantation pro-grammes. At the same time, the pursuit of self-sufficiency is apublic project, based on the community-oriented values ofreciprocity, solidarity, equity, and voluntary donation.Community involvement is essential to successful trans-plantation programmes, which depend on public partici-pation at every level. All members of the population needto be engaged as participants in the development of anorgan donation culture, and as stakeholders in the goal ofuniversal access to the benefits of transplantation. To thisend, transplantation authorities have a responsibility tobuild organ procurement systems and transplant pro-grammes that are endorsed by society and are transparentin their outcomes and processes.

Meeting the needs of patients not only means providingaccess to transplantation but also investing in the prevention ofend-stage organ failure. Significant global variation in incidenceof end-stage organ disease, for example, a 3-fold differencein the incidence of end-stage kidney disease in Norwaycompared with the United States, clearly demonstrates thepotential of prevention to reduce transplantation needs(10). Prevention is inherent to the objectives of Transplan-tation Authorities and professionals and must besupported as such. Furthermore, minimization of trans-plantation needs through prevention is the only feasibleapproach to self-sufficiency in resource-poor settingswhere cost and infrastructure requirements preclude thedevelopment of transplantation services. An example of aneffective prevention programme running on limited re-sources has been underway for several years in rural Indiaand has had demonstrated success in reducing mean bloodpressure and blood glucose in the target population (17).Prevention of end-stage organ failure starts with primaryprevention: promotion of healthy lifestyles and basic pre-ventive interventions including vaccination.

In addition to concerted efforts in prevention, thepursuit of self-sufficiency requires the development ofeffective deceased donation programmes, complementedby organ donation from living persons. Identifying andmobilizing potential resources to maximize donation fromdeceased persons, through transparent and ethical prac-tices that respect society’s values and universal humanrights and principles, is a priority. Only certain types oforgans can be donated by living donors, moreover livingorgan donors face a variety of risks ranging from the im-plications of undergoing eligibility testing to the potential

complications of organ removal, which may be physical,social, financial, or psychologic. The highest possible levelof protection of living donors must be ensured, which re-quires maximizing donation from deceased donors, so thatthe need for living donors be kept to a minimum. Dona-tion after death is also considerably more effective thandonation from living persons; a single deceased donor mayprovide upward of three organs for transplantation (18).An average deceased donor in the United States has beenestimated to provide an additional 30.8 life years sharedbetween 2.9 recipients (19). Optimal utilization of de-ceased donor potential requires the existence of appropri-ate legislative and organizational frameworks, effectivecoordinating authorities, and community awareness of theimportance of organ donation and participation as regis-tered donors. Public education, including health educa-tion in school curricular, will contribute to awareness andsupport this objective.

The pursuit of self-sufficiency offers a framework forapproaching the challenge of organ shortages that isgrounded in community participation and intersectoral andinterdisciplinary cooperation. The scope of this goal encom-passes disease prevention, legislation and regulation, imple-mentation of organizational infrastructure, donation, andpublic education, as complementary elements of a compre-hensive strategic approach to the needs of patients and thecommunity at large. Self-sufficiency also frames organ dona-tion and transplantation in a broader health services contextand is strongly concerned with health equity and ethical prac-tice. Adopting the goal of self-sufficiency emphasizes that ac-cess to transplantation should not be the prerogative of aprivileged few but rather that transplantation programmesshould be a feature of comprehensive and well-organizedpublic healthcare systems. Enhancing collaboration betweenthe different agencies and organizations working in areas thatinfluence transplantation needs and resources will optimizethe efficiency, efficacy, and quality of healthcare services pro-vided and has the potential to greatly advance the goals oftransplantation medicine and of public health.

The Pursuit of Self-Sufficiency as a Global Objective

The Role and Responsibilities of Health Authorities in thePursuit of Self-Sufficiency

The human right to health and dignity implies a rightto the recognition of all human needs for transplantation.Therefore, practically and ethically, self-sufficiency must beconceived as a common global goal. Action, however, beginslocally. The intrinsic requirements of organ donation andtransplantation programmes in terms of resources, organiza-tion, and regulation are responsibilities of the State, and theprocurement of human body components from living anddeceased persons rightly falls under State jurisdiction. Fur-thermore, governing authorities have political and ethical ob-ligations to promote the health and protect the interests oftheir citizens, for which there is a reciprocal duty of citizens tocontribute to shared public goods such as transplantation.That is, all members of society who stand to benefit fromorgan donation have a duty to participate in organ donationafter death, where eligible to do so. A corollary of this is thatpersons and populations who are excluded from a potential



Box 2

Special report from India: Dr. Rakesh Kumar Srivastava, Director General of Health Services, Ministry of Health and Family Welfare, Government of India

Transplantation in India faces significant challenges with respect to the large burden of end-stage organ failure in the country, a lack of necessary infrastructure, organization and coordination of health services, low awareness and negative attitudes toward organ donation, andthe costs of treatment. The incidence of end-stage kidney disease in India is estimated to be 150 to 175 per million population per year (or between 150,000 and 175,000 cases) and is attributable to diabetes in 30 to 40% of patients (20,21). Liver failure affects approximately 50,000 persons per year, with HBV as one of the common causes. Heart failure similarly affects approximately 50,000 persons per year. Tomeet this burden of disease, India has 180 renal centers, 25 liver centers, and 10 cardiac centers for transplantation, staffed with 160 renal surgeons, 25 liver surgeons, and few cardiac surgeons. Of these facilities, approximately two thirds are located in South India, and 80% arein the private sector.

Organizational challenges include uncoordinated trauma care, the absence of a national coordinating network to provide oversight and regulation of organ donation and transplantation activities, and underdevelopment of public-private partnerships that could improve

access to transplantation services. In addition, multitude donor cards have been introduced by multiple agencies with a lack of organization of these and other activities in organ donation. A lack of awareness about organ donation and transplantation is found at both the public andprofessional level, and religious reservations and negative attitudes toward organ donation are pervasive. Finally, the direct and indirect financial costs of transplantation surgery and maintenance are prohibitive. For example, the cost of immunosuppression using tacrolimus, steroid, and mycophenolate is US 350 to 400 per month, or nearly US 5000 per year (21). Transplantation is, however, achieved at much lower cost than in high-income countries, in particular through the use of generic immunosuppressants. Also, insurance schemes do exist that may assist with the cost of treatment for some patients.

India passed the Transplantation of Human Organs Act (THOA) in 1994. This legislation introduced regulation of transplantation for therapeutic purposes, legal acceptance of brain death, and prohibition of commercial dealings in human materials with penalties in the event of violations of the law. In recent years, the provisions of the Act have been the focus of a national consultation process intended to introducelegislative reforms that will improve rates of donation from deceased persons and support living-related transplantation. Plans for reform tothe Act include a renaming to “The Transplantation of Human Organs and Tissues Act,” inclusion of grandparents and grandchildren in thedefinition of near relatives, recognition of procurement centers, approval of paired donor exchanges, making it mandatory for the treating staff to request relatives of brain-dead patients for organ donation, and mandatory creation of transplant coordinator positions in all hospitalsperforming transplantation. Further reforms include accreditation of laboratories, simplification of brain-death certification committees, the establishment of a National Transplant Registry, revisions to forms and procedures, and greater regulation surrounding women, minors, andforeign nationals.

Currently, India performs approximately 4000 kidney transplants per year, 250 liver transplants, 10 heart transplants, and 25,000 corneal transplants. Kidney transplantation activity is predominantly based on living donors. With the aim of improving organ availability and increasing transplantation, the government is planning to start the National Organ Transplant Programme (NOTP). The objectives of theNOTP are to minimize end-stage organ failure, treat end-stage organ disease patients, promote organ donation from deceased persons, centralize organ procurement and distribution systems, and strengthen transplantation infrastructure and coordination on a national scale (11). In this capacity, the NOTP is establishing new facilities for transplantation, strengthening existing facilities, conducting training activities, and is establishing a National Tissue and Biomaterial Centre. Additional strategic activities of the NOTP include an information, education and communication campaign concerning the legal provisions of the THOA and organ donation, and activities aimed at reducing the costs of transplantation. Other recent organizational achievements for organ donation and transplantation programmes in India include the beginnings of public-private partnerships, the growth of state-based and other networks, for example, an Armed Forces Organ Retrievaland Transplant Authority, reform of the donor card system, and increasing advocacy for donation after death through media engagement, involvement of key opinion leaders, celebrity endorsements and public events such as World Kidney Day.

Finally, India is also taking steps toward managing its population burden of diseases contributing to end-stage organ failure. Despite limited budgetary support for public health, several comprehensive prevention initiatives have been implemented. Examples include the National Rural Health Mission and the National Programme for Prevention and Control of Diabetes, Cardiovascular Diseases and Stroke. Additional initiatives include an integrated disease surveillance programme, introduction of universal HBVvaccination, a tobacco law and programme initiative, and a national alcoholpolicy. Intersectoral health promotion efforts will also contribute to decreasingthe burden of these diseases.

Organization and activities of the proposed National Organ Transplantation Programme of India

NOPDO

SOPDO

• Maintaining waiting list • Transplant registry• Co-ordination for procurement• Dissemination of information • Creating awareness• Training activities• Follow-up • Monitoring of transplantation • To operate various schemes • Data management

• Retrieval centers• Transplant centers• Diagnostic centers and labs• Public interface

Zonal

NOPDO: National Organ Procurement and Donation Organization SOPO: State Organ Procurement and Donation Organization


Box 3

Special report from China: Professor JieFu Huang, Vice Minister, Ministry of Health, Peoples’ Republic of China

Today, China performs the second largest number of organ transplants in the world at a rate of approximately10,000 transplants per year. Nearly, all forms of transplantation are performed in China: transplantation of kidneys commenced in 1969, followed by pancreas transplantation in 1989, liver in 1993, small intestine in 1994, and heart and lung in 2003. Achievements for organ donation and transplantation programmes in China include the development of basic and clinical research, standardization of transplantation techniques,the rapid expansion of clinical applications, training of a large number of skilled young medical professionals, international knowledge exchange and cooperation, and significant improvements in post-transplantation survival rates and patient management.

However, the development of organ donation and transplantation in China has also experienced problems, most particularly with respect to commercialization of organs, transplant tourism, and an overreliance on organs obtained from executed prisoners, a source of deceased donor organs that is not consistent with international ethics and standards of practice. These problems are compounded by scarcityin the supply of organs available for transplantation and the lack of a national system for organ donation and allocation that is subject to appropriate oversight and regulation. There are approximately 1 million end-stage kidney disease patients on maintenance dialysis and approximately 300,000 terminal liver disease patients requiring organ transplantation in China. The lack of a legal, sustainable, and sufficientdonor pool to meet the needs of this vast number of end-stage organ failure patients is the greatest challenge for facing transplantation programmes in China. Organ procurement, allocation, and recipient selection are currently hospital based without centralized standards or a transparent registry system. Regulations have lagged behind medical progress, with transplantation therefore expanding in an unregulated manner (8). Some hospitals trade with illegal organ agencies and sell organs to foreigners for profit. The illegal trade in human organs that hasemerged in China has created a tremendous profit chain that runs contrary to the principle of equity and the goal of building a harmonious society.

Ethical organ transplantation is not possible without the development of ethical organ donation processes and a regulated organ allocation system. Donation of organs from deceased individuals must be dependent on the good will of individuals and families in a system of voluntary donation with informed consent, moving away from the current system in which more than 90% of grafts are obtainedfrom executed prisoners. Additional safeguards introduced to protect the rights of row inmates include the requirement for written consent to organ removal from the donor and the right to review of all death sentences by the Supreme People’s Court. The long-term goal for socialdevelopment is to abolish the death penalty; however, until such a time, regulations are needed to protect the individual rights of prisoners and to separate transplantation programmes from the prison system (8).

Since the implementation of the Regulation on Human Organ Transplantation in May 2007, which introduced bans on transplant tourism and established an accreditation system for clinical transplantation services, a significant decrease in liver transplants to foreign nationals has been reported, with the number of liver transplants in non-Chinese patients decreasing from 624 in 2006, to 2 approved casesin 2009. Under the accreditation system, which provides a framework of baseline requirements and guidelines, only 163 hospitals have beengranted a license to perform organ transplantation. Since the enforcement of the Regulation, the certificates of seven accredited hospitals have been revoked, and eight physicians’ licenses have been suspended. Reforms have also had the effect of decreasing the number of deceased donor transplants being performed in Chinese citizens and have prompted a dramatic increase in living-related kidney and liver transplantation over the past 2 to 3 years. In addition, driven by the scarcity of available organs and by profiteering by organ brokers, organs sales by the poor and vulnerable are increasing.

The future development of organ transplantation in China requires that a national transplantation programme be established that provides oversight, is responsible for the implementation and monitoring of organ procurement andtransplantation programmes, and is able to increase administrative efficiency by maintaining a balance of authority between central and provincial governments. The National Organ Transplantation Work Scheme outlines a systematic project plan for the development of China’s organ transplant system,conceived within a broader context of healthcare reform and development. The Scheme involves five goals: promote voluntary donation; enable efficientorgan procurement and utilization; ensure equity, justice, and transparency inallocation; establish quality assurance processes and establish a scientific registry for organ transplantation. Registries will inform the policymaking processes of the National Organ Transplantation Committee (OTC) and help to ensure the highest professional standards in the delivery of transplant services. Internationally recognized medical criteria regarding patient priority ranking, organ matching, allocation, and sharing principles will be adopted by the OTCand specialist committees. OTC policy states that “National waiting list andorgan allocation systems shall be established to address medical needs of patients and ensure the principles of equality, justice and transparency.” To support the implementation of these policies, The Ministry of Health has developed the China Organ Allocation and Sharing Computer Network.

China is planning additional regulations for this new phase in transplantation. Working Conferences have generated initiatives concerning brain death (Beijing, April 2008) and organ donation (Shanghai, August 2009). Most recently, the Red Cross Society of China,together with the Ministry of Health, commenced a pilot programme of DCD. Launched in March 2010, this programme involves public education, a campaign to register donors, and provides guidelines for organ allocation. DCD potentially offers a means to expand the donorpool in a practical and ethical way, thereby reducing the demand pressures driving the illegal or gan trade and the overreliance on unethical organ sources. With the support of the Red Cross Society of China, China is working toward building an effective and ethical deceased donation programme, based on the principle of altruism, which balances the demand for organs against a framework of values acceptableto Chinese society. ■

National Organ Transplantation Work Scheme, P.R. China

5 Scientific Registries for Organ Transplantation

Establish a scientific based policy-making process

4Accreditation System for Clinical Transplantation (163 certified hospitals)

Quality assurance Accreditation systems for hospitals/professionals Establish guidelines for clinical practice

3 China Organ Allocation and Sharing System

Ensure equality, justice and transparency National Waiting List Organ Matching System

2National Organ

Procurement Organization System (OPOs)

Ensure effective use of transplantable organs

1 National Organ Donation Campaign

Establish a donor registration system Promote organ donation Voluntarism



share in the unique benefits of transplantation must be pro-tected from practices that outsource the burden of organdonation. Similarly, the burden of donation should not beunjustly imposed on particular members or groups within apopulation. In all circumstances, the duty to donate is limitedby the right not to be harmed.

The practical implementation of self-sufficiency strategieswill vary for different populations; however, the inherent valuesof the self-sufficiency paradigm and the key elements of theWHO Guiding Principles should guide policy and be reflected inpractice in all contexts. The pursuit of self-sufficiency and theadoption of ethical practices in organ procurement and trans-plantation are mutually reinforcing. Approaches to self-suffi-ciency that uphold the interests and well-being of all members ofa population will naturally conform to principles of justice, harmminimization, and respect for human dignity.

Countries with low economic and health sector de-velopment may lack much of the basic infrastructure re-quired for the development of domestic organ donationand transplantation programmes, such as transplant sur-geons, intensive care facilities, suitable storage facilities,and adequate diagnostic services. However, the pursuit ofself-sufficiency is not conditional on a particular level ofresources. Indeed, national approaches to self-sufficiencyshould be conceived within the context of the widerhealthcare system, be consistent with public health goals,and must take account of the immediate needs of the pop-ulation and available resources. Achievements in the pur-suit of self-sufficiency should be celebrated with respect torelevant benchmarks that acknowledge the relative re-source constraints and the unique challenges facing dona-tion and transplantation in different populations. For ex-ample, the successful implementation of a public healthprogramme to prevent a disease that contributes to theneed for transplantation in one country should be consid-ered as important as an increase in donation rates in an-other. Progress toward self-sufficiency will take time, butthe potential benefits extend well beyond organ donationand transplantation to include practical consequences forhealth systems and the reinforcement of societal values ofequity, transparency, solidarity, and social justice.

The Crucial Contribution of Health Professionals to thePursuit of Self-SufficiencyJeremy ChapmanPresident, TTSFrancis DelmonicoDirector of Medical Affairs, TTS

Health professionals have a crucial contribution tomake to the pursuit of self-sufficiency as the medical interfacewith patients, as advocates for patients, and in developingand exchanging technical expertise. Global leadership inthe field of transplantation medicine is provided by TTS.The Society has specific responsibilities in the develop-ment of the science and clinical practice of transplantation,in scientific communication among physicians and re-searchers, in supporting the continuing education of pro-fessionals engaged in transplantation, and in providingguidance to professionals on ethical practice. Contributingto the pursuit of self-sufficiency, TTS aims to provide acomprehensive education programme in the science and

clinical practice of transplantation, designed to improvepatient outcomes through greater competence and perfor-mance of its members, the medical community, and thegeneral community.

TTS acts as consultative technical body to its membersand Sections, to national and regional societies and theircountry affiliates, to governmental and non-governmentalorganizations, to related international societies such as theGlobal Alliance for Transplantation, and to international or-ganizations such as the WHO. In this capacity, TTS providesexpertise in establishing deceased donor programmes and ad-vises on standards of care for living donors. TTS actively sup-ports the work of the WHO by implementing the resolutionsof the WHA as they apply to the fields of cell, tissue, and organtransplantation.

A key mission of TTS is to take measures to protect thepoorest and vulnerable groups from transplant tourism andthe sale of tissues and organs, including attention to the widerproblem of international trafficking in human tissues andorgans. The Declaration of Istanbul arose from concernsshared by TTS, the ISN, and the WHO regarding the ongoingproblems of international organ trafficking and the globalshortage of organs for transplantation. TTS is now leadingtask forces that are systematically assisting professional orga-nizations, scientific journals, pharmaceutical companies, pa-tients, and governments with the objective of promulgatingand implementing the Declaration of Istanbul. The mandateof these task forces is to:

• Reach colleagues through professional organizationsand assist with practical implementation of the princi-ples of the Declaration of Istanbul;

• Ensure all possible relevant organizations are contacted tofacilitate communication with the Declaration of IstanbulCustodian Group (DICG) and provide suggestions regard-ing activities following endorsement;

• Communicate the details of the Declaration of Istanbulto national and institutional review boards, ethics com-mittees, and ethics review organizations;

• Assist medical and scientific journals in (a) requestingthat authors of articles relating to clinical organ trans-plantation disclose whether the clinical and research ac-tivities being reported conform with the principles of theDeclaration of Istanbul, and (b) establishing editorialprocesses for determining the appropriateness of accept-ing presentations on clinical transplantation, based onthe disclosure of their conformance with the principlesof the Declaration of Istanbul;

• Communicate the details of the Declaration of Istanbul tosponsors and funders of clinical transplantation research;

• Integrate into all clinical transplantation trials, adoptionof the Principles of the Declaration of Istanbul, alongsidethe Declaration of Helsinki and Good Clinical PracticeGuidelines;

• Respond to knowledge about individual patients subjectto transplant tourism, commercialism, and trafficking;

• Promote the welfare of individual donors and recipientsin the global environment;

• Provide an annual report on regional and nationalorgan trafficking and tourism and other develop-ments related to the Declaration of Istanbul (such as


new legislation, criminal proceedings against trans-plant centers, and professionals);

• Coordinate the work of DICG Emissaries through definingtheir terms of reference, collating information from theEmissaries and providing communication to the DICG;

• Engage governments to endorse principles of the Declara-tion of Istanbul and to persuade them of the value of incor-porating the principles into clinical practice;

• Distinguish actions required by Governments both withand without transplantation services with respect toboth citizens and foreigners;

• Communicate with Ministries of Health and empha-size the role of the Declaration of Istanbul as a profes-sional ethical standard fully consistent with the WHOGuiding Principles for Human Cell, Tissue, and Or-gan Transplantation.

In addition, TTS is currently undertaking efforts to col-lect data concerning cross-border transplant procedures, toensure that these are regulated and comply with agreed qual-ity and safety standards. TTS, along with its Sections, associ-ated agencies, and members, has a central role in the pursuitof self-sufficiency and is committed to provide ongoing lead-ership in working toward this goal.

The Critical Pathway: the Process of Donation FromDeceased DonorsFrancis DelmonicoDirector of Medical Affairs, TTS

A structured deceased donor management algorithm is auseful tool by which countries with existing deceased donationprogrammes may evaluate performance in the utilization ofpossible deceased organ donors. It also provides a frame-work for policy in countries seeking to develop effectivetransplantation programmes from the ground up. A criti-cal pathway for organ donation is presented in Figure 2.The essential features of this critical pathway are as follows:

• A possible deceased organ donor is a patient with devas-tating brain injury or lesion or a person with a circula-tory failure, who is apparently medically suitable fororgan donation. The critical pathway is designed to ret-rospectively, and prospectively, consistently assess thisspecific patient population. Patients may only becomedonors after death, and organ recovery must not causedeath. The identification and referral of a possible donoris the role of the treating physician.

• DBD and DCD are both to be considered under the crit-ical pathway.

• DBD: on recognition of a possible deceased donor by thetreating physician responsible for the patient, the possi-ble donor becomes a potential donor when his or herclinical condition fulfils death by neurologic criteria.Once the potential donor is declared dead, he or she isconsidered an eligible donor if medically suitable for organdonation. An actual donor is a consented eligible donor inwhom an incision has been made with the intent of organrecovery or an organ has been recovered. If a malignancy isdiscovered during the operative procedure (or any othercontraindication to organ donation is noted), the organrecovery procedure may be discontinued. The patient maystill, however, be categorized as a deceased donor. A utilized

donor is an actual donor from whom at least one organ hasbeen transplanted into a recipient.

• DCD: a potential DCD donor is a person for whomthe withdrawal of life support is planned because fur-ther treatment would be futile; yet brain death has notoccurred, usually because the patient is spontaneouslytaking a breath. After the withdrawal of life support,the cessation of circulatory and respiratory functionsis anticipated within a timeframe (up to 2 hr) that willenable recovery of a viable organ. If the patient doesnot die within that period, organ recovery is not per-formed. A potential DCD donor is also defined as theperson whose circulatory and respiratory functionshave ceased and resuscitative maneuvers are not to beattempted or continued. An eligible DCD donor is amedically suitable person who has been declared deadbased on the irreversible absence of circulatory andrespiratory functions as stipulated by the law of therelevant jurisdiction, within an appropriate time-frame that organ recovery is possible. The remainderof the critical pathway for eligible DCD donors is thesame as for DBD donors.

Application of the critical pathway algorithm in clinicalpractice may identify specific reasons why a potential organdonor has not been converted into a utilized donor. Avoid-able disruption of the critical pathway includes: (1) failure toidentify a potential or eligible donor; (2) failure to completebrain death diagnosis because of lack of resources or person-nel able to make the diagnosis; (3) failure to declare circula-tory death within the appropriate timeframe; (4) logisticalproblems, for example, the lack of a recovery team; (5) inabil-ity to identify a compatible recipient; (6) damage to organsmade during their recovery; (7) inadequate perfusion of or-gans or thrombosis; or (8) consent is denied by the donor orhis or her family. An essential step in the critical pathway isthe notification of organ donation personnel. Referral mayoccur when the pathway establishes a possible deceased organdonor, when a potential DBD or DCD donor is identified, orwhen eligibility of the potential DBD is established. Alterna-tively the family themselves may raise the possibility of organdonation.

The critical pathway for organ donation is a core outcomeof the Madrid Consultation. Evaluation of the performance oforgan donation and transplantation programmes should takeaccount of this pathway and the goal of recovering as many or-gans as possible by converting possible and potential donors toutilized donors. There are some clear immediate barriers to thisgoal, for example, the fact that DCD is not legally accepted insome countries in Europe. Adoption of the clinical pathway inclinical decision making and its use as a reference for policy mak-ers will facilitate the development of deceased donation pro-grammes that optimize efficiency and efficacy in the recoveryand transplantation of deceased donor organs.

Global Status Report on Organ Donation andTransplantation: Current Activities and Progressin the Pursuit of Self-Sufficiency

European RegionValentina HafnerWHO Regional Office for Europe



The European region is the global leader in organ do-nation from deceased persons. Of the 31,628 solid organtransplants reported in the region in 2008 (40.5 per millionpopulation), 85% were from deceased donors (7) (Fig. 5). Yetthese figures conceal significant variation in organ donationand transplantation activity across the region; Europe en-compasses both the highest performing deceased donorprogramme in the world (Spain), and multiple MS with notransplantation activity or infrastructure. Despite this varia-tion, the pursuit of self-sufficiency in organ donation andtransplantation is conceived as a shared European ambition.The WHO Guiding Principles (22), the EU’s regulatoryframework (23), and the protocols developed by the Councilof Europe (24), guide consistency in European regulatoryframeworks and processes and promote a common attitudetoward transplantation issues. European cooperation is con-cerned mainly with the dissemination of best practice in reg-ulated organ donation and transplantation environment-s,and protection of vulnerable populations and eliminationof transplant tourism.

The provision of safe, effective, and sufficient trans-plantation services across the European region faces sev-eral challenges. Uneven health service development, andpolitical, organizational, and cultural diversity across MStranslates into differences in legislative backgrounds, vari-ation in donor and recipient management, and differencesin public perceptions toward organ donation and trans-plantation. This adds to potential epidemiologic threats(4) and pressure on health service delivery because ofgrowing cross-border movement. The aim of Europeancooperation and collaboration in the development of pro-fessional capacity, galvanization of political will, and pro-motion of public awareness is, ultimately, to develop organdonation and transplantation programmes across the Eu-ropean region that maximize transplantation rates and aresimultaneously based on understanding and respect ofethical principles, human dignity, and social justice.

Effective national legal frameworks consistent withthe WHO Guiding Principles are essential component of

this goal. The promotion of organ donation and transplan-tation across the European region necessitates a publichealth perspective, to avoid potential distortionary im-pacts on national health priorities. Increased attentionneeds to be given to health promotion, disease prevention,early treatment, and diagnosis of conditions potentiallyleading to organ failure and other transplant needs, mini-mizing the gap between demand and availability.

The Chisinau Statement of 2009 (25) extends Europeancollaboration and knowledge sharing on issues of quality,safety, and access to transplantation services, based on eth-ical principles and respect for human dignity, to the newlyindependent states of Armenia, Belarus, Georgia, Kazakh-stan, Kyrgyzstan, Republic of Moldova, Tajikistan, and Uz-bekistan. Most of these states now have specific transplant legis-lation, although not all have established a transplantationauthority. As MS develop their national transplantation pro-grammes, European collaboration is expected to provideongoing support in the form of practical assistance andtechnical advice to ensure quality of care, regional net-working, and opportunities for regular consultation tobenchmark status, map progress, share concerns, and pro-duce solutions.

African RegionJean-Bosco NdihokumbwayoWHO Regional Office for Africa

Transplantation activity in the 46 MS of the African regionis minimal and is typically confined to kidney transplantationfrom living donors. Activity in the 6 countries that conducttransplantation (Algeria, Kenya, Mauritius, Nigeria, Ghana, andSouth Africa) ranges from 305 organs transplanted in SouthAfrica during 2008, to 1 kidney transplanted in Ghana (7).South Africa alone performs transplants from deceased do-nors, although Algeria is beginning to develop its owndeceased donor programme. Demand for organs in theAfrican region is great and is growing, driven by anincreasing prevalence of chronic diseases, especially hyper-tension, and by the enormous regional burden of infec-tious risk factors for end-stage organ disease, includingHBV and HIV. Coordinated, sustained approaches to theprevention of noncommunicable diseases (NCDs) in theregion are absent, reflecting low awareness and minimalallocation of funds to support prevention efforts (26).Therefore, the gap between demand and capacity to pro-vide transplantation is rapidly widening.

The scarcity of transplantation in Africa correspondswith the limited capacity of health systems in the region todeliver resource-intensive transplantation programmes.Additional barriers to provision of transplantation in theAfrican region include the lack of access to affordable im-munosuppressive drugs and to adequate diagnostic ser-vices, including imaging, pathology, and histocompatibil-ity laboratories. Such challenges are compounded by anabsence of oversight and regulation of organ donation andtransplantation activities, and a legislative and regulatoryvacuum that leaves populations vulnerable to exploitation.Low- and middle-income countries constitute easy targetsfor the exploitation of poor and vulnerable individualswhen they lack legal protection. The magnitude of these

FIGURE 5. Distribution of transplantation activities ineach World Health Organization region in 2008. Propor-tions attributable to deceased donors (DD) and livingdonors (LD) are shown. Value labels give overall rate (ab-solute transplants performed).


problems in the African region is not well known, consis-tent with a general opacity surrounding regional activities,practices, and outcomes in organ donation and transplan-tation in the absence of reliable data.

Collaboration between African countries, or be-tween Africa and other regions/international agencies, forthe purpose of enhancing knowledge, skills, and resources,is currently limited. Greater regional and internationalcollaboration and cooperation might contribute meaning-fully to the future of organ donation and transplantation inthe African region by: (1) providing technical support andtraining; (2) supporting efforts to identify affordabledrugs, equipment, and consumables; (3) consulting onoversight, organization, and coordination of organ dona-tion and transplantation programmes; and (4) facilitatingregional cooperation in the development of deceased do-nor transplantation. Development of greater expertise inthe practice of transplantation and increased resourcing oftransplantation services in African countries with existingtransplant programmes have the potential to produce an-cillary benefits for the health services, including improve-ments in pathology and imaging services, surgery, and gen-

eral medicine, while also contributing to improved qualityof medical education and of tertiary care at large.

Few countries in the African region have establishedspecific transplantation legislation under national healthlaws or any form of regulatory oversight with respect toorgan donation and transplantation. Currently, 5 of 46MS in the African region have transplantation legislationin place (South Africa, Algeria, Mali, Senegal, and Coted’Ivoire). Hence, the African region faces the simultaneouschallenges of a large vulnerable population lacking legalprotection from exploitation, an expanding population inneed of organs, and an absence of many of the essentialservices necessary to meet minimal standards for the pro-vision of transplantation services. Although the extent oforgan trafficking and related forms of exploitation in theregion is unknown, the combination of these factors haspotential to jeopardize patients, medical teams, and trans-plantation services. There is therefore a critical need forimproved regulation and oversight of all aspects of trans-plantation in the region, so that risks to patients and com-munities may be controlled. For African countries, the firststeps toward self- sufficiency will be to raise political

Country study: Russian Federation

Sergey Gautier Director, National Research Center of Transplantology and Artificial Organs President, Russian Transplantation Society

Despite the introduction of a Federal Transplantation Law based on the WHO Guiding Principles for Human Cell, Tissue and Organ Transplantation and adoption of presumed consent in 1992, and the availability of a legal definition of brain death since 1987, organ donation and transplantation in the Russian Federation remained at a critically low level until 2006. The annual rate of kidney transplantation did not exceed 3.0 per million population, and for other organs, the transplantation rate did not exceed 1.0 per million population (27, 28). However, a number of organizational, legislative, economic, and educational changes have resulted in recent positive trends in transplantation rates.

Russia has 34 transplant centers located in 19 cities, of which 33, 8, 5, and 3 perform kidney, liver, heart, and pancreas transplantation, respectively. Almost all transplant centers are located on the European side of the country; therefore, organ donation and transplantation activity occurs in only 14 of 84 regions in the Federation. Furthermore, it is the 41.6 million residents of these 14 regions (29.3% of the total population) comprise the potential deceased donor pool for the entire country. The mean rate of donation from deceased persons in these 14 regions is 8.8 donations per million population, decreasing to 2.6 donations per million population when the whole population is considered.

From 2006 to 2008, there was a marked increase in the deceased donor rate in these 14 regions. The total number of utilized deceased donors reached 381 in 2009, an increase of more than 60% since 2006 (27). There was also a 39% increase in the 12 months from 2008 to 2009 in the number of living kidney and liver transplants. Contributing to increases in the rate of donation from deceased persons has been increases in the both rate of brain death diagnosis and in the rate of multiorgan procurement. A lack of extrarenal transplantation programmes in the majority of transplant centers, however, has meant that multiorgan procurement has already begun toplateau. DCD accounts for approximately 50% of kidney transplants.

There is a need for greater popularization of organ donation in the Russian Federation, for dissemination of information about the process of organ donation, and for public reassurance concerning the successful results of transplantation procedures. The Federation consists of 500 different nationalities, each with individual cultural attitudes toward organ donation, and therefore, engagement with religious and other community leaders is necessary to overcome a widespread lack of awareness concerning organ donation and transplantation in the population. Poor awareness and information extends to medical professionals; medical education needs to be improved to provide specific teaching on principles of organ donation, organ procurement, and organ sharing. There is also a need to settle unresolved legal questions and to improve regulation and coordination at the federal level. The Russian Transplantation Society is working with the developing a federal transplant coordination system and nationwide database and registry. Pediatric deceased donationand informed consent for parents remains an unsettled legal area.

Despite recent improvements, transplant activity in the Russian Federation remains vastly insufficient compared with population needs. There is a significant and unrealized potential of donation from deceased persons, meaning that the preconditions exist for considerable growth of solid organ transplantation with greater development of regional and federal coordination systems for organ donation and transplantation. Key challenges in the pursuit of self-sufficiency will be to extend organ procurement to include a greater proportion of the population and to build support for organ donation and transplantation among medical professionals. ■



awareness of these challenges and to sensitize national au-thorities to the critical importance of legal frameworks,based on the WHO Guiding Principles.

Eastern Mediterranean RegionNabila MetwalliWHO Regional Office for the Eastern Mediterranean

The Eastern Mediterranean region, extending from Af-ghanistan to Morocco and including some African countrieswith complex emergencies such as Sudan, Somalia, and Dji-bouti, is full of diversity. Concerning organ donation and trans-plantation, challenges for the region include unevenly distrib-uted wealth, and consequently healthcare infrastructure,minimal interest in prevention of chronic disease, and lowawareness among medical professionals and communities re-

garding the importance of organ donation. Donation after deathis rare because of social reservations and ongoing debates sur-rounding brain death; therefore, transplant activity in the regionpredominantly involves kidney and partial liver transplantsfrom living donors. Waiting lists for organ transplantation aregrowing rapidly, but in the absence of significant investment intransplantation services or access to organs from deceased do-nors, many patients have sought alternative solutions in theform of commercial transplantation. The region contains coun-tries with significant problems in terms of organ trafficking, bothdocumented and undocumented; wealthy individuals who needorgans for transplantation import the vendors from poor MS. TheWHO,withthecooperationofdedicatedindividualsinthefield,hasbeen able to introduce legislation against this practice in a few MSand is very proud of the results. Implementation is yet to follow.

Country study: Nigeria

Adewale Akinsola Nephrologist and Head of Renal Unit, Department of Medicine, Obafemi Awolowo University

Nigeria is the most populous country in West Africa, with a population of 150 million, comprised predominantly of young adults. HIV, are highly prevalent. Like most countries in the region, Nigeria

faces a concurrent, growing burden of noncommunicable disease. Hypertension is found in approximately 10% of adults, and rates of diabetes mellitus are increasing (29). Community-based studies estimate a prevalence of chronic kidney disease as high as18% to 20% (30), and there has been a surge in the representation of chronic kidney disease among hospital admissions over recent years (21, 24

Hypertension is the biggest single case of chronic kidney disease in Nigeria, as in most of sub-Saharan Africa, followed by glomerulonephritis (including secondary glomerulonephritis related to malaria, HIV, filariasis, schistosomiasis, HBV, HCV, and SLE). Currently, only approximately 5% of chronic kidney disease is attributable to diabetes mellitus (26). Other contributing risk factors include analgesic intake, the use of herbal and alternative medicine, poor access to health care, and a reluctance to seek out health services. End-stage kidney disease in Nigeria is predominately a disease of young adults (30–40 years) from low socioeconomic background. Presentation is typically late in the course of disease progression and is accompanied by a high comorbidity burden (31).Poor access to treatment means mortality is more than 95% (32).

Communicable diseases, particularly tuberculosis, malaria, and

Arogundade and Barsoum 2008).

Primary health care in Nigeria provides free immunization and basic services, including maternal/child health care, subsidized by the government. Tertiary health care is available in specialist/teaching hospitals located near major cities. Government funds cover staff and equipment only; all costs of treatment are covered by the patient. Nigeria has had a national health insurance scheme for about 5 years, which covers less than 1% of the population for primary andsome secondary care services, but not for tertiary services such as dialysis or organ transplantation. Nonetheless, the provision of dialysis services through both public and private facilities has seen rapid growth in recent times. The maintenance dialysis population in Nigeria is estimated to be between 500 and 600 patients; however, this reflects only 5% to 10% of population of patients actually requiring dialysis (>6000). These are patients who are able to afford more than 2 months of dialysis through personal funds or sponsorship by government agencies or private organizations. Prevention programmes targeted at the causes of end-stage organ disease currently do not exist in Nigeria. Strengthening primary health care to include detection of chronic disease risk factors for the prevention of chronic disease and end-stage organ failure is an important goal. Adequate population studies and national registries are also needed to generate reliable data on end-stage organ failure and its

Transplantation activities are confined to a small programme based on living donors. Kidney transplantation was commenced in 2001, and Nigeria now has 4 transplant centers with a combined capacity to perform approximately 30 to 40 transplants per yearMore than 90% of transplanted organs come from living related donors, and first year survival of patients transplanted in Nigeria is approximately 95%. In 2008, total transplantation activity consisted of 14 kidney transplants from living donors. Transplantation facilities, equipment, and trained personnel are severely limited, as are diagnostic services and expertise. The huge cost of medicationsand laboratory and radiologic investments adversely affect the quality of immunosuppression, ongoing graft management, and patientmanagement and workup. Legislative and regulatory frameworks are absent, as are competent authorities responsible for oversight of transplant activities, practices, and donor and recipient outcomes.

The expansion of transplantation activity in Nigeria depends on addressing these regulatory and resource deficits. Public-private

partnerships for sustainable financing of transplantation services are needed. Financing needs also to provide for subsidization of individuals unable to afford the expense of transplantation, to promote greater equity access to treatment. Expansion of national medical insurance may also be appropriate. Regional and international collaboration has an important role in building technical capacity and in the development of deceased donor transplant programmes in Nigeria. Finally, increasing population awareness of organ donation and transplantation is necessary to support organ procurement and to address adverse sociocultural attitudes regardingmedical interventionl, which can lead to delayed presentation and difficulties for graft maintenance. ■

treatment.


Responding to the obligations of WHO MS with re-spect to effective national oversight, accountability, andthe protection of vulnerable groups from transplant tour-ism (WHA 57.18/2004) is an important challenge facingthe Eastern Mediterranean region. Prevention of an inter-national trade in organs has been gathering momentum,including significant recent progress in instituting regula-tory and legal frameworks consistent with The Declarationof Istanbul. Saudi Arabia, Kuwait, Tunisia, and Moroccohave led the region in the regulation and technical devel-opment of organ donation and transplantation. In March2010, transplantation law was also passed in Egypt. Thislaw bans the commercial trafficking of organs, restrictsdonation from living persons to family members, permitsregulated deceased donation, and undertakes to financetransplant procedures for low-income patients. Also inMarch 2010, President Asif Ali Zardardi of Pakistan signedinto law a bill prohibiting the sale of organs and providingfor organ donation to occur after death (http://www.emro.who.int/pressreleases/2010/no2.htm).

Antipathy toward donation after death has been a ma-jor challenge in the Eastern Mediterranean region. Religiousleaders are now leading normative change and building com-munity support for donation after death by advocating organtransplantation, from both living and deceased donors, asbeing upheld by the Quran as a charitable and life-saving act.Registration as a potential deceased donor is being encour-aged on the basis of religion, motivation to be a participant ina responsible society, and a responsibility to contribute togreater equity by increasing the donor pool, so that access totransplantation is possible across all sectors of society (a re-jection of an allegorical notion of “pharos and slaves”). Do-nation from deceased persons is currently performed inTunisia, Iran, Saudi Arabia, Lebanon, and Kuwait, with thesecountries soon to be joined by Egypt and Pakistan. Syria and

Iran are also now moving toward expanding deceased dona-tion programmes.

The foundations are in place for unprecedented na-tional efforts to maximize organ donation from deceasedpersons in the Eastern Mediterranean region. These effortswill be met by ongoing challenges of regulation, organiza-tion, and coordination, and by the need to firmly establishpublic awareness and community support through ongoingcampaigns and effective media engagement. Appropriate mod-els of organization and financing need to be developed that in-corporate public and private healthcare providers in locallyappropriate, regulated organ donation and transplantation sys-tems that are transparent and acceptable to the community. Pro-cedures for evaluating and making determinations on newdevelopments of legal, ethical, or religious concern, for exampleDCD, may also facilitate the continuing advancement of de-ceased donor programmes within the region.

South East Asian RegionMehta GeetaWHO Regional Office for South-East Asia

The South East Asian region is home to approximately25% of the world’s population and approximately 30% of theglobal burden of disease. Communicable diseases, especiallytuberculosis and HIV, are highly prevalent. However, it ischronic diseases—CVD, cancer, chronic lung disease, anddiabetes—that are the leading cause of death in the region.This dual chronic and infectious disease burden is com-pounded by high neonatal and maternal mortality, and by thecomplex challenges of emerging diseases such as endemicavian influenza. Epidemiologic data on end-stage organ fail-ure for the region is sparse. India (33) and Thailand (34)report an incidence of end-stage kidney failure of approxi-mately 150 to 175 cases per million population per year,higher than the incidence of end-stage kidney disease re-

Country study: Egypt

Mohamed Hilal El Sahel Teaching Hospital

Egypt commenced living donor kidney transplantation in 1980, introducing liver transplantation from living donors in 2002. An extremely high burden of end-stage liver disease and hepatocellular carcinoma is found in the Egyptian population. It is estimated that 42,000

individuals are currently in need of a kidney or liver transplant [ vs. 1280 transplants performed in 2008; (7)].

The national government has introduced a comprehensive primary prevention strategy to control the spread of HCV; however, it is estimated that the number in need of

transplants will exceed 100,000 by 2020 years based on the current population burden of HCV infection.

Disagreement over the definition of brain death, questions of social injustice, and ethical debates concerning the ownership of organs

of disease has helped to inflate the problem of a compatible living donor, the large, unmet burden of disease has helped to inflate the problem of commercial organ sales in the country, and Egypt has become a regional hub for organ trafficking.

The passing of a transplantation law prohibiting organ trafficking, legalizing donation from deceased persons, and coordinating donation from living persons by the Egyptian Parliament in March 2010 represents a significant step both toward addressing the transplantation needs of the Egyptian population and bringing an end to wide spread trafficking. The Egyptian law stipulates that a Licensefor Organ Transplantation will only be issued to adequately equipped facilities that are able to comply with strict standards and adhere to rigorous inspections from the High Committee of Organ Transplantation. It is intended that this new legal framework will be the foundation of an organ donation and transplantation programme characterized by transparency, legality, donor and recipient safety, equity in access to transplantation therapy, and a national culture of organ donation.

In 2010, Egypt is at a crossroads in organ donation and transplantation. Immediate challenges are to establish organizations responsible for organ procurement, construct a formal waiting list, and begin to generate community support for donation after death.

Subsequent needs include the articulation of organ allocation criteria, construction of a donor and recipient registry, building depth of experience in brain death diagnosis, and the promotion of an organ donation culture within the health system.■

prevented the legalization of donation after death in Egypt until 2010. As the only hope for Egyptian patients with end-stage organ failure


http://www.emro.who.int/pressreleases/2010/no2.htm

http://www.emro.who.int/pressreleases/2010/no2.htm


ported by most European countries. Glomerulonephritis andinterstitial diseases, associated with communicable diseasesand environmental toxins, were historically the most com-mon causes of end-stage kidney failure in the South EastAsian Region but are now being taken over by diabetes, whichis rapidly emerging as the single most common cause of kid-ney failure in the region (33, 35).

Of the 11 South East Asia region MS, six (Indonesia, India,Thailand, Sri Lanka, Myanmar, and Nepal) are currently en-gaged in transplantation activity and have national plans for or-gan donation and transplantation programmes at varying stagesof implementation. More than 220 health facilities in the regionperform solid organ transplantation, of which 65% are in theprivate sector. Approximately 7000 kidneys, 300 livers, and 10hearts are transplanted each year, with the majority of this activ-ity taking place in India, followed by Indonesia, Thailand, and SriLanka (7). However, 94% of kidneys and 70% of livers trans-planted in South East Asia are obtained from living donors.Thailand alone has a significant deceased donation pro-gramme. The high burden of end-stage organ disease inSouth East Asia, combined with undeveloped deceased dona-tion programmes, together contribute to a vast disparity be-tween the need for organs and access to transplantation in theregion and tempt unethical practices. Although the major-ity of MS have established legal frameworks regulatingdonation and transplantation, commercialization andtrafficking continue to be reported.

The pursuit of greater self-sufficiency in organ dona-tion and transplantation for the South East Asian region firstrequires that national plans for organ donation and trans-plantation programmes be extended to include the develop-ment of deceased donation. As in other regions, the successfulexpansion of organ donation and transplantation pro-grammes relies on widespread community awareness of theimportance of organ donation and participation as registereddonors. It will be necessary to build on legal frameworks toensure adequate regulation of all donation and transplanta-tion practices and to combat the persistence of unethicalpractice in the sector. Finally, public-private partnershipsshould be promoted as an appropriate and sustainablemethod of financing organ donation transplantation inemerging economies, able to promote greater equity in accessto transplantation by persons in need.

Western Pacific RegionGayatri GhadiokWHO Regional Office for the Western Pacific

Of the 27 MS of the Western Pacific region, 10 havetransplantation facilities (Australia, NZ, China, Korea, VietNam, Philippines, Japan, Mongolia, Singapore, and Malay-sia). Organ donation and transplantation involving foreigndonors and recipients traveling for this purpose is permittedby some countries in the region, although this is closely reg-ulated. The Western Pacific is highly heterogeneous with re-spect to economic development, accounting for much of thevariability in the distribution of transplantation activity, al-though this variation also presents opportunities for coun-tries seeking to develop organ donation and transplantationprogrammes (most recently Fiji) to draw on long-establishedregional expertise in transplantation.

Significant heterogeneity is also found with respect to theutilization of organs from deceased donors in the Western Pa-cific region. Transplantation in Viet Nam, Mongolia, Philip-pines, Japan, the Republic of Korea, and Singapore is based pre-dominantly on organs from living donors. Only in Australia,New Zealand, and China, do deceased donors outnumber liv-ing donors. The shortage of organs from deceased donors is akey challenge in the pursuit of self-sufficiency in the WesternPacific region. Despite high economic development andlong-established transplantation programmes, Australia andNew Zealand achieve rates of deceased donation consistentlybelow the global average (39). In Japan, where the burden ofend-stage kidney disease is among the largest in the world (34),debate concerning the definition of brain death has impededthe development of deceased donation. Other donation-related issues that present ongoing challenges in the regioninclude allocation processes, traceability of organs, and trans-parency of procurement and transplantation. There is a scopefor greater regional cooperation, including collaboration toshare technical capacity and to meet training needs, improvedlaboratory coordination, and development of common qual-ity and safety systems. Registries and databases for donormatching, surveillance of adverse events, and monitoring oforgandonationandtransplantationactivitiesarewell-establishedinsome MS but underdeveloped in others. Finally, a tacit communityacceptance of transplant tourism and commercial organ transplan-tation exists that has not yet been adequately addressed throughlegislative and regulatory frameworks.

Greater self-sufficiency in organ donation and trans-plantation in the Western Pacific requires principally thatnational legal frameworks be strengthened and imple-mented, consistent with the WHO Guiding Principles forHuman Cell, Tissue, and Organ Transplantation, and thatdeceased donation programmes be developed as a matterof priority.

American RegionJose Luis Di FabioWHO Regional Office for the Americas

Transplantation activities in the American region arehighly variable. Rates of organ donation from deceased personsrange from 6.29 deceased donors per million population forLatin America as a whole to 26.3 donors per million populationin the United States. Within Latin America, there is a large diver-sity in transplantation activity, influenced by variability with re-spect to economic factors, political commitment to transplanta-tion programmes, and the organization of healthcare systems.Countries that have had the benefit of continuous governmentcommitment to organ donation and transplantation pro-grammes, such as Uruguay, Chile, Columbia, Cuba, Argentina,and Brazil, demonstrate the highest rates of organ donation andtransplantation in the region, and have shown systematic, ongo-ing improvements for the past 5 to 10 years (43, 42).

Latin America serves as a model for internationalcooperation and collaboration in the sharing of knowl-edge, skills, and resources. Training of transplant coordi-nators from Latin American countries by Spain in the early90s established a precedent of Iberoamerican cooperationfor the development of donation and transplantation pro-grammes in Latin America. This exchange of knowledgeand skills has been progressively formalized, and in 2005,


the XV Iberoamerican Summit of the Heads of State and Gov-ernment ratified a proposal to create the Red/Consejo Ibe-roamericano de Donacion y Trasplante, with the mandate toimprove organ donation and transplant programmes in LatinAmerican through international linkage with ONT and via pro-motion of intraregional cooperation and collaboration. Red/Consejo Iberoamericano de Donacion y Trasplante has devel-oped numerous recommendations for implementation at thenational level and has also developed an ongoing human re-sources training programme (the Master Alianza). As of March2010, more than 180 transplant coordinators from across LatinAmerica had been trained in Spanish hospitals in all aspects ofthe coordination of organ donation and transplantation and hadreturned to their respective countries to apply their expertise.

Supported by a strong network of collaborations and anactive exchange of information, experience, training, and re-sources, Latin America has managed to address many of thechallenges that in other regions act as barriers to the effectivedelivery of organ donation and transplantation programmes.Recent years have seen several Latin American countries achieveconsiderable success in their organ donation and transplan-tation programmes. The existence of appropriate and effec-tive legal frameworks in most Latin American countries, theemergence of strong national organizations for the promo-

tion, coordination, and regulation of organ donation and trans-plantation, the development of data registries, the systematichigh-quality training of transplant coordinators, and an increas-ing equity of access to organ transplantation are enormousachievements for the region.

Key Points and SummaryA global overview of current activities in organ dona-

tion and transplantation demonstrates that, despite widevariation in health service capacity, legislative backgroundand cultural perceptions relating to organ donation, the chal-lenges confronting individual countries with respect to thepursuit of self-sufficiency are often shared in common. Al-though the characteristics of successful organ donation andtransplantation programmes may differ from country to coun-try, the factors essential for progress toward self-sufficiency areaffirmed in all contexts, regardless of local realities.

Essential for every country is a commitment to: (1) re-ducing need through disease prevention and (2) establishinglegislative frameworks based on respect of ethical principles,human dignity, and social justice. Profound social and eco-nomic changes in low- and middle-income countries, accom-panied by rapidly changing patterns of diet and exercise, arepromoting escalating rates of CVD, diabetes, and other chronic

Country study: Thailand

Visist Dhitavat Thai Red Cross Organ Donation Center

Thailand’s Organ Donation Centre was established under the Thai Red Cross Society in 1994. Founded in 1893, the Thai Red Cross Society is the oldest, non-governmental, non-profit organization in Thailand. In addition to overseeing organ donation and transplantation activities, the Thai Red Cross Society is responsible for the National Blood Bank and Eye Bank. These organizations, with a common goal of obtaining cells, tissues and organs for transplantation, also share common laboratory support in HLA typing and microbiology.

The policies of the Organ Donation Centre have been developed in accordance with recommendations outlined by the Thai Medical Council, the WHO Guiding Principles, and the ethics committee of The Transplantation Society. These governing policies are; first, to promote an understanding of organ donation after death among the public and health professionals to have enough organs for transplantation in the country; second, to allocate organs fairly and without financial gain; and third, to optimize efficiency in the utilization of donated organs. The specific functions of the Centre incorporate almost all aspects of the organ donation and transplantation process, including maintenance of an organ donation registry and a national waiting list, organ matching and allocation, organ preservation and transport, coordination between donors and recipient hospitals, donor family care, increasing public awareness of the critical need for organs, and maintenance of a Heart Valve Bank (36–38).

The Organ Donation Centre has been responsible for extensive public awareness campaigns to promote understanding and greater support for organ donation and transplantation in Thailand. Multimedia campaigns, employing film and television advertising, print media, television programming, celebrity endorsements, poster campaigns, handbills, lecture tours, and exhibitions, have been used in the effort toraise awareness and to address specific topics such as brain death, organ donation and Buddhism, the shortage of available organs, the process of organ donation, and the efficacy of transplantation. In addition, the venerable Buddhist monk Phra Phromkunaporn (Prayuth Payutto) has written on the merits on organ donation to address misconceptions regarding donation and transplantation in the predominantlyBuddhist Thai population. Events have been used to raise the profile of organ donation, including “The Organ Donation Day,” an annual event during which the Organ Donation Centre organizes religious ceremonies to honor donors and publishes a booklet with words contributed from recipients and from donors’ families. Private enterprises have also contributed to awareness campaigns, producing phone cards, and stamps printed with messages affirming the value of organ donation.

The Organ Donation Centre also provides training in transplant coordination, donor management, and organ recovery and conducts visits to provincial hospitals to educate professionals on the donation process and on the importance of transplantation. Education is also extended to medical and nursing students. Currently, Thailand has 638 transplant coordinators across 131 hospitals. The country has 31 kidney transplant centers, 10 liver transplant centers, and 5 heart transplant centers, of which 17 are located in private hospitals and 29 in government hospitals. However, although transplant waiting lists have more than doubled since 2001, the number of deceased donors has remained less than 100 per annum, fluctuating according to changes in public confidence and disturbances in healthcare operations affecting organ donation (36–38). There is approximately an 80% refusal rate from families approached regarding donation after death.

The major obstacles to improve the rate of donation after death in Thailand are the lack of an appropriate legislative framework, thelack of governmental and public health policies supporting organ donation and transplantation, poor awareness among medical professionalsof the value of organ donation, and refusal of consent by families of potential donors. Solutions will require a commitment from the Ministry of Health to increase donation from deceased persons and the introduction of a legal definition of brain death as a priority.■



diseases. This epidemiologic transition will alter the nature of thedemand for health services in those countries affected, withglobal implications for organ donation and transplantation.Where there is a high burden of end-stage organ failure,combined with undeveloped deceased donation and an ab-sence of regulation, there is also the temptation of uneth-ical practices. The importance of legislative frameworks,consistent with the WHO Guiding Principles, cannot beunderstated. However, it must be noted that regulation isineffectual unless adequate resources are channeled into itsimplementation, which requires political commitment,and that legislation can only bring about the desiredchange when it is sanctioned by public attitudes. A need toengage communities to build awareness concerning theimportance of organ donation and the benefits of trans-plantation was identified in all regions.

Finally, the current era in transplantation is seeingthe beginnings of widespread international efforts to over-

come traditional cultural, legislative, and organizationalbarriers to the development of deceased donation pro-grammes. There is a central role for international cooper-ation and collaboration in facilitating these efforts,through the sharing of knowledge, skills and resources,data sharing, training programmes, and advocacy on issuesof shared concern. Increasing access to transplantationglobally by maximizing donation from deceased persons,complemented by donation from living persons, throughpractices that respect society’s values and universal humanrights and principles, is central to future progress in the pur-suit of self-sufficiency.

Closure of the Meeting and Closing RemarksParticipants agreed on adopting a Resolution stress-

ing a national responsibility to meet the needs of patientswith respect to organ transplantation, as guided by theWHO Guiding Principles for Human Cell, Tissue, and Or-

Country study: Singapore

Anantharaman Vathsala National University of Singapore, Department of Medicine

Singapore conducted its first corneal transplant in 1964, followed by the first kidney transplant from a deceased donor in 1970 and first kidney transplant from a living-related donor in 1976. Legislation was introduced in 1973 in the form of the Medical Therapy, Education and Research Act and was followed by the introduction of the Human Organ Transplant Act in 1987, which subsequently has undergone several amendments reflecting developments of a scientific or social nature relevant to the Act. Transplantation law in Singapore provides for the removal of organs from the bodies of deceased persons for transplantation purposes and prohibits trade in organs. Presumed consent has been gradually phased-in, incorporating different sections of the population in a step-wise fashion. The 1987 Act provided for the removal of kidneys from persons who had died from accidents only and exempted Muslims and persons more older than 60 years from the provisions of the Act; in 2004, the Act was amended to allow organ donation from all deaths and to provide for liver, heart, and corneal in addition to kidney donation; in 2008, Muslims were included in presumed consent, and; in 2009, the upper age limit for organ recovery was removed.

There is now a recognized need for Singapore to focus on the development of “soft skills,” to fully realize the potential of the country’s established legislative framework and existing transplantation infrastructure. The “Live On” programme has been developed to address public education and community motivation, policy development and implementation, engagement of the government and public agencies, and in innovations in practice. Public awareness of the importance of organ donation is the target of an annual SGD1.5 million media campaign that involves the distribution of an information booklet to all households, the utilization of news media, and campaigns directed at youth (such as short story competition and use of social networking websites). There is evidence that this programme is havinga positive effect on attitudes towards organ donation, with 64% of people surveyed responding that they now support organ donation morethan they did before to the roll-out of the programme.

Concerns for living donor welfare and for financial hardship incurred by donors and recipients have prompted a number of organizational and legislative developments in recent years. Singapore has established a Donor Care Registry to monitor the long-term health outcomes of all donors, for life. Counseling and education are provided to all potential living donors, who must also go through a “cooling off” period before proceeding with donation. Amendments have been made to the policies of national health providence fund (Medishield) to exempt living donors from exclusions or premium loading. In addition, the Human Organ Transplant Act has been revisedto include provision for the defraying or reimbursing of (1) costs or expenses or loss of earnings directly attributable to organ donation and(2) costs for medical care or insurance protection incurred as a consequence of organ donation. The Singaporean National Kidney Foundation has established the NKF Fund for needy donors, which provides annual medical follow-up and insurance protection covering hospitalization and surgery, death, disability, and critical illness. At the same time, legislation prohibiting the buying or selling of organs is being widened to prohibit advertisements relating to buying or selling of organs and to introduce stricter penalties for organ trading syndicates and middlemen. Singapore’s first organ trading case was prosecuted in August 2008, and ensuring ethical practice in organ donation and transplantation is a priority. Currently, a living donor organ transplant can only be carried out following the approval of thehospital’s Transplant Ethics Committee.

The incidence of end-stage kidney disease in Singapore has remained stable at 150 to 175 per million population for the past decade. During the same period, however, the rate of kidney transplantation has also remained relatively static at 25 to 40 transplants per million population per year (40). It is hoped that comprehensive chronic disease prevention programmes will complement efforts to increase the transplantation rate by reducing rates of end-stage organ failure. Programmes include the Integrated Screening Programme, which screens for diabetes, hypertension, and hyperlipidemia in the general community, the Pre-Diabetes Intervention Programme, and the Chronic Disease Management Programme. The Pre-Diabetes Intervention Programme, in which individuals with impaired fasting glucose are referred to nurse educators for assessment, counseling, and follow-up, has already been shown to be effective in decreasing mean blood glucose level in programme participants. Therefore, backed by a detailed legislative framework, Singapore is pursuing a composite approach to self-sufficiency that places emphasis on both successfully reducing demand for organs and increasing the transplantation rate.■


Country study: Uruguay Inés Alvarez Instituto Nacional de Donación y Trasplante

Uruguay has some of the highest reported rates of end-stage organ failure in the American region but is also the highest performing country with regards to organ donation and transplantation in Latin America. Significantly, the majority of transplanted organs in Uruguay

come from deceased donors (deceased donor rate of 19.1 donors per million population).

The first kidney transplant in Uruguay was performed in 1969; regulation of transplantation activity followed in 1971. Initial legislation defined consent and prohibited trafficking and commercialization, while subsequent amendments have addressed donation fromnon related, living persons, definitions of circulatory and brain death, and xenotransplantation (41). A nationally integrated health system provides universal healthcare coverage. Since 1980, access to transplantation has similarly been free and universal. Financing of organ donation and transplantation is based on regulated private systems with public assistance. Uruguay also established a separate national donor registry and tissue bank, responsible for typing and allocation, early in the development of their programme to facilitate quality control, and also to ensure transparency to the wider community. One of the strengths of Uruguay’s organ donation and transplantation programme has been the incorporation of community values. There is a community perception of equity of access, real possibilities of transplantation, and transparency of allocation systems (41).

On this foundation, Uruguay has sought to increase rates of donation from deceased persons by aligning organ procurement practices with the Spanish model. Transplantation is governed by a publicly financed, national governmental organization, responsible for regulation, implementation of national policy, procurement management, and monitoring and quality control of organ donation and transplantation practices in Uruguay (Instituto Nacional de Donación y Trasplante de Células, Tejidos y Órganos, INDT). Since the introduction in 2000 of hospital-based transplant coordinators under INDT, actualized donor rates have more than doubled ( 42). In 2006, a quality assurance programme was introduced to analyze theoretical national capacity for deceased donation, to monitor donation and transplantation practices,and to evaluate for improvement. Recent emphasis has also been placed on improving professional awareness and on public education, promoting a donation culture across the community.

Uruguay has also benefitted from a strategic focus on regional cooperation and linkages, with Brazil and RCDIT in particular, and from an emphasis on specialist training and continuing medical education, reflecting the core values of the Uruguayan organ donation and transplantation programme: sharing, discussion, and consensus. Central to the pursuit of self-sufficiency in Uruguay are public education, the promotion of a donation culture, ongoing professional training in both the medical and communication aspects of organ donation and transplantation, and fostering of best-practice in the detection of potential donors.■

Box 4

Common challenges in the pursuit of self-sufficiency

From low-income countries to high-income countries, many of the challenges facing organ donation and transplantation are shared in common. Successfully addressing these mutual challenges will often involve similar strategies and in some cases will depend on international cooperation and collaboration. These common challenges are as follows:

• The growing demand for organs affects low-, middle- and high-income countries alike, with need far outstripping current transplant capacity in the majority of countries.

• The global burden of diseases contributing to end-stage organ failure is immense, and therefore, organ donation and transplantation efforts must be complemented by sustained and comprehensive public health approaches to the prevention of diabetes, hypertension, cardiovascular disease, HBC, HCV, and chronic pulmonary disease.

• Reliable epidemiologic data on rates of end-stage organ failure are not available; hence, appreciation of actual transplantation need is currently not possible.

• Registries for the purpose of monitoring organ donation and transplantation activities must be comprehensive and accurate. National surveillance systems that monitor adverse events in transplant recipients and complications in live donors are critical.

• A minimal set of legal provisions concerning the removal of human material for therapeutic purposes from deceased and living donors is essential to protect the vulnerable from exploitation; however, unregulated settings persist.

• Ongoing regulatory improvement is a requirement for all regions. National bodies responsible for oversight of organ donation and transplantation activities are commonly absent.

• Low-income countries are uniquely challenged to provide diagnostic services (imaging, pathology, and histocompatibility laboratories)and by the unaffordability of immunosuppressive drugs. International support is needed to address these issues.

• Achieving transparency in allocation practices and equity in access to transplantation is a challenge wherever there is disparity between the number of patients in need and the number of organs available for transplantation. It is particularly challenging in settings where inequity is entrenched within the broader health system.

• Financing of organ donation and transplantation must seek to make effective use of private and nongovernmental funds and public-private partnerships in a locally appropriate manner.

• Promotion of transplantation and the expansion of deceased donation must avoid distortion of existing health priorities in disease prevention and be commensurate with local realities.



gan Transplantation, and acknowledging that meeting theneeds of patients necessitates a comprehensive approach thataddresses the conditions leading to transplantation from pre-vention to treatment. Strategies for the pursuit of self-sufficiencywithin individual countries should be adapted to the respec-tive level of economic and health system development, withthe pace of progress from one level of transplantation capa-bility to the next commensurate with local resource availabil-ity and competing health priorities. Transplantation pro-grammes should use resources obtained within a givencountry for that country’s population or, when necessary,resources may be obtained by regulated and ethical regionalor international cooperation.

This new paradigm advances a comprehensive stra-tegic framework for policy and practice directed at theglobal challenges of an increasing incidence of chronicNCDs, a shortage of organs for transplantation, and unmetpatient needs. From this perspective, donation and trans-plantation services are to be recognized as an integral com-ponent of the health system, rather than as a marginal,superspecialized type of tertiary care. The need to interactwith next of kin at the time of death mandates that profes-sionals and organizations involved in donation and trans-plantation services engage with the public on an ongoingbasis to promote greater recognition and understanding oforgan donation. Likewise, professionals involved in dona-tion and transplantation must present themselves to thepublic as concerned for the health of all, not only the healthof potential recipients, and demonstrate medical empathyas much as technical professionalism.

The consultation was officially concluded by Dr.Jose Martinez Olmos, General Secretary of Health ofSpain, who underlined how the concept of self-sufficiencydoes not only stress the necessity to increase the availabilityof resources within a given population to meet transplan-tation needs but also the necessity to decrease actualtransplantation needs within that population and to en-

hance cooperation between the different stakeholdersinvolved.

From a public perspective, the pursuit of self-sufficiencyrelies on a communal appreciation of the value of organ do-nation after death. The concept of donating human bodyparts to save the life of another as a civic gesture is one thatshould be taught at school as a part of health education todecrease needs in transplants. The pursuit of self-sufficiencyin organs for transplantation exemplifies the public healthand community values of reciprocity and solidarity, whereasit is the only safe guard against the temptation of yielding totrade in human organs.

The consultation was officially concluded by Dr JoseMartinez Olmos at 14:35 on the March 25, 2010.

REFERENCES1. Steering committee of the Istanbul Summit. Organ trafficking and trans-


2. WHO Guiding Principles; WHA 63.22/2010 Available at: http://www.who.int/transplantation/en/.

3. Matesanz R, Marazuela R, Dominguez-Gil B, et al. The 40 donors permillion population plan: An action plan for improvement of organdonation and transplantation in Spain. Transplant Proc 2009; 41: 3453.

4. Grossi PA, Fishman JA. Donor-derived infections in solid organ trans-plant recipients. Am J Transplant 2009; 9(suppl 4): S19.

5. Humar A, Morris M, Blumberg E, et al. Nucleic acid testing (NAT) oforgan donors: Is the ‘best’ test the right test? A consensus conferencereport. Am J Transplant 2010; 10: 889.

6. Ison MG, Hager J, Blumberg E, et al. Donor-derived disease transmissionevents in the United States: Data reviewed by the OPTN/UNOS DiseaseTransmission Advisory Committee. Am J Transplant 2009; 9: 1929.

7. Organ donation and transplantation: Activities, laws and organization.2008 Report of the Global Observatory on Donation and Transplanta-tion. World Health Organization and Organizacio�n Nacional de Tras-plantes, March 2010. Available at: http://www.transplant-observatory.org/.

8. Huang J, Mao Y, Millis JM. Government policy and organ transplan-tation in China. Lancet 2008; 372: 1937.

9. Delmonico FL. The implications of Istanbul Declaration on organ traffick-ing and transplant tourism. Curr Opin Organ Transplant 2009; 14: 116.

Box 5

Shared goals on the pathway to self-sufficiency

Repeatedly identified across all regions of the globe are a common set of factors essential to the successful pursuit of self-sufficiency in organ donation and transplantation. These are:

• Regional/international cooperation for the exchange of knowledge, skills and, resources.

• Political sensitization to the need for adequate legislative frameworks based on the WHO Guiding Principles for Human Cell, Tissue and Organ Transplantation.

• National regulation and oversight of organ donation and transplantation.

• Community awareness of the importance of organ donation and participation in efforts to increase rates of transplantation.

• A culture of organ donation within the medical community.

• Access to national and international databases that cover all aspects of organ donation and transplantation, from population need, to long-term donor and recipient outcomes.

• Processes for quality assurance, monitoring the gap between potential and achieved donation.

• Incorporation of community values in organ donation and transplantation programmes; normative change led by political, religious, and community leaders.

• International cooperation in specialist training and continuing medical education.

• Sufficiently transparent financing, organ procurement, and allocation processes that the public, as potential donors themselves, are satisfied that the system is not being used to generate financial rewards, and is otherwise free from unethical or inequitable practices.

• National and international commitment to prevention.





http://www.transplant-observatory.org/

10. Hallan SI, Coresh J, Astor BC, et al. International comparison of therelationship of chronic kidney disease prevalence and ESRD risk. J AmSoc Nephrol 2006; 17: 2275.

11. Imai E, Matsuo S. Chronic kidney disease in Asia. Lancet 2008; 371:2147.

12. Wen CP, Cheng TY, Tsai MK, et al. All-cause mortality attributable tochronic kidney disease: A prospective cohort study based on 462 293adults in Taiwan. Lancet 2008; 371: 2173.

13. Zhang L, Zhang P, Wang F, et al. Prevalence and factors associated withCKD: A population study from Beijing. Am J Kidney Dis 2008; 51: 373.

14. Wild S, Roglic G, Green A, et al. Global prevalence of diabetes: Esti-mates for the year 2000 and projections for 2030. Diabetes Care 2004;27: 1047.

15. Fukuhara S, Yamazaki C, Hayashino Y, et al. The organization andfinancing of end-stage renal disease treatment in Japan. Int J HealthCare Finance Econ 2007; 7: 217.

16. Pretagostini R, Peritore D, Di Ciaccio P, et al. Exchange of organs andpatients with foreign nations during the first 15 months of activity ofthe Italian gate to Europe. Transplant Proc 2007; 39: 1739.

17. Mani MK. Prevention of chronic renal failure at the community level.Kidney Int Suppl 2003; 83: S86.

18. Ojo AO, Heinrichs D, Emond JC, et al. Organ donation and utilizationin the USA. Am J Transplant 2004; 4(suppl 9): 27.

19. Schnitzler MA, Whiting JF, Brennan DC, et al. The life-years saved by adeceased organ donor. Am J Transplant 2005; 5: 2289.

20. Agarwal SK, Dash SC, Irshad M, et al. Prevalence of chronic renalfailure in adults in Delhi, India. Nephrol Dial Transplant 2005; 20: 1638.

21. Agarwal SK, Srivastava RK. Chronic kidney disease in India: Challengesand solutions. Nephron Clin Pract 2009; 111: c197; discussion c203.

22. Revised WHO Guiding Principles on Human Cell, Tissue and OrganTransplantation; Document A63/24. Available at: http://apps.who.int/gb/ebwha/pdf_files/A62/A62_15-en.pdf

23. Directive 2004/23/EC (OJ L 102, 7.4.2004, p. 48–58); Commission Directive2006/17/EC (OJ L 38, 9.2.2006, p. 40–52); Commission Directive 2006/86/EC(OJL294,25.10.2006,p.32–50);Directiveonstandardsofqualityandsafetyofhuman organs intended for transplantation, June 2010

24. Guide to safety and quality assurance for organs, tissues and cells, 2ndEdition. Council of Europe, September 2004, Strasbourg [ISBN 92-871-5518 – 6]

25. 2nd Consultation of Tissue and Organ Transplantation for the NewlyIndependent States, March 9 –10, 2009. WHO Regional Office for Eu-rope, 2009; available to: http://www.euro.who.int/pubrequest

26. Arogundade FA, Barsoum RS. CKD prevention in Sub-Saharan Africa:A call for governmental, nongovernmental, and community support.Am J Kidney Dis 2008; 51: 515.

27. Gautier SV, Moysyuk YG, Minina MG, et al. Trends in organ donationand transplantation in Russia. Analysis of 2006 –2008 national registrydata. Transpl Int 2009; 22(suppl 2): 65.

28. Manyalich M, Nanni Costa A, Paez G. IRODat 2008 International donationand transplantation activity. Organs Tissues Cells 2009; 12: 85.

29. Akinkugbe OO, Akinyanju OO. Non-communicable diseases in Nige-ria. Report of a National Survey, Federal Ministry of Health and SocialServices, Lagos, Nigeria. Ibadan, Nigeria, Spectrum Books Ltd 1992.

30. Abioye-Kuteyi EA, Akinsola A, Ezeoma IT. Renal disease: The need forcommunity-based screening in rural Nigeria. Afr J Med Pract 1999; 6: 198.

31. Akinsola A, Adelekun TA, Arogundade FA, et al. Magnitude of theproblem of CRF in Nigerians. Afr J Nephrol 2004; 8: 24.

32. Arogundade FA, Sanusi AA, Akinsola A. Epidemiology, clinical char-acteristics and outcomes in ESRD patients in Nigeria: Is there a changein trend? Nephrology 2005; 56(suppl 1): A56.

33. Modi GK, Jha V. The incidence of end-stage renal disease in India: Apopulation-based study. Kidney Int 2006; 70: 2131.

34. Annual data report 2009. United States Renal Data System, NationalInstitutes of Health, Bethesda, MD, 2009.

35. Jha V. Current status of end-stage renal disease care in South Asia. EthnDis 2009; 19(1 suppl 1): S1–S27.

36. Nivatvongs S, Dhitavat V, Jungsangasom A, et al. Organ donation pro-gram to honor the 60th anniversary of the King’s accession to thethrone. Transplant Proc 2008; 40: 2095.

37. Nivatvongs S, Dhitavat V, Jungsangasom A, et al. Thirteen years ofthe Thai red cross organ donation centre. Transplant Proc 2008; 40:2091.

38. Nivatvongs S, Dhitavat V, Jungsangasom A, et al. Recent organ trans-plantation situation in Thailand. Jpn J Transplant 2008; 43: 423.

39. Excell L, Hee K, Russ G, eds. ANZOD Registry Report 2010. Australiaand New Zealand Organ Donation Registry, Adelaide, SA.

40. Vathsala A, Chow KY. Renal transplantation in Singapore. Ann AcadMed Singapore 2009; 38: 291.

41. Alvarez I, Bengochea M, Mizraji R, et al. Three decades of the history ofdonation and transplantation in Uruguay. Transplant Proc 2009; 41: 3495.

42. Mizraji R, Perez S, Alvarez I. Activity of transplant coordination inUruguay. Transplant Proc 2007; 39: 339.

43. Mizraji R, Alvarez I, Palacios RI, et al. Organ donation in Latin Amer-ica. Transplant Proc 2007; 39: 333.


http://www.euro.who.int/pubrequest


Part 2: Reports From the Working Groups

WORKING GROUP 1: ASSESSING NEEDSFOR TRANSPLANTATION

Leaders: Christian Jacquelinet, Vivekanand Jha, andAdeera Levin

Members: Manuel Arias, Gloria Ashuntantang, SaeedBassam, Eemi Vera, Sveinn Magnusson, Rosario Marazuela,Nabila Metwalli, Ferdinand Muehlbacher, Kaija Salmela, andZhong Yang Shen.

A Common Framework for the AccurateAssessment of Transplantation Needs

In an attempt to move toward sustainability and self-sufficiency with respect to organ donation and transplanta-tion, nations must use a common framework and set ofmetrics. The goal of defining these metrics is that by doing so,a broader understanding of the gaps and issues facing differ-ent countries will be more apparent. Solution generation anddissemination may be facilitated if we start with a greaterglobal understanding of the issues that currently exist.

Organ transplantation is the part of a continuum of careand health, which commences with recognition of risk factors,documentation of chronic conditions, and management of end-stage organ failure, which includes identification of the optimaltreatment of that organ failure. Thus, a better understanding oforgan transplantation requires an appreciation of the interactionbetween population needs, healthcare systems, and the availabil-ity of living and deceased donors as a source of grafts. It is wellrecognized that organ availability varies widely between andwithin countries, because of different combinations of cultural,ethical, religious, social, organizational, and practical issues. Fur-thermore, the care and outcomes of patients with failing organsvaries depending on the organ affected.

Strategies for greater self-sufficiency in organ donationand transplantation must be informed by the accurate assess-ment of the needs of populations. Therefore, recognizing thediversity of outcomes, situations, and challenges facing trans-

plantation in different countries, internationally applicablemetrics are required, which will support a consistent globalapproach to transplantation needs assessment. Through thecomparison of a common set of key indicators, it is possible toestablish the notion that end-stage organ failure and trans-plantation are indeed global issues; thus, the assessment ofneeds across regions and political and geographical boundaries,based on a framework of internationally applicable metrics,should stimulate comparisons, discussions, and ultimately com-mon solutions to similar problems.

The Requirement for Common Metrics andDefinitions

The requirement for common metrics and definitionshas several aspects:

a. A need for the clear identification of need according tostandard definitions:

• We strongly advocate for inclusivity of case reporting.That is, all cases of (incident) end-stage organ failure mustbe documented irrespective of treatment availability,cause, or eligibility/availability of organ replacement (trueneed). The availability of treatments introduces bias andmust be acknowledged as a limitation of current metricsavailable and in current use around the world. Reportingof true need will help to focus public and political atten-tion on the problem of insufficient donor organs availableto meet transplantation needs.

• Organ failure in all age groups and of all organs so as toensure a true reflection of societal burden of illness.

b. A need for the clear identification of drivers of need: thisincludes the identification of the number of individualswith multiple conditions to highlight the complexity ofconditions, and the linkage between multiple organ dys-function and end-stage organ failure within individuals.

Key Points • The application of an internationally consistent framework to the assessment of transplantation needs will enable a broader

understanding of the issues facing different countries, and facilitate the identification of global solutions. Yet there is currently a paucity of the necessary metrics, tools, and definitions required to make standardized needs assessment possible.

• An international organ transplantation registry, using common definitions and metrics, should be established. For the purposes of this registry, the following national-level data should be made available: (i) true incidence and prevalence of end-stage organ failure, reported annually, (ii) availability of treatment for end-stage organ failure, (iii) waiting-list statistics, (iv) data relating to the identification of organ dysfunction and progression to organ failure, (v) referral to organ replacement therapy (transplant and non transplant), and (vi) time for workup, time to acceptance onto waiting list, and time to receipt of an organ.

• Governments should: (i) support identification of transplantation needs as a priority for public health improvement; (ii) create a registry for conditions leading to the need for organ transplantation; (iii) invest in prevention programmes; (iv) ensure the equity principle is applied in need assessment; and (v) create or support infrastructure and allotment of resources for all aspects of need assessment.

• The WHO should: (i) identify as a resolution that all countries shall have the ability to assess their needs for transplantation by 2020; (ii) identify and outline the need for a core minimum data set by which international comparisons will become meaningful.

• Professional societies and their members should: (i) ensure consistency in definitions and use of terms; (ii) support identification of organ failure /dysfunction as a strategic priority for the organization; (iii) foster international cooperation and intra-societal cooperation; (iv) support education concerning technical issues in needs assessment; (v) promote scientific enquiry in the area of needs assessment; and (vi) ensure linkages with governmental agencies and policy makers for translation of research into policy.


c. A need for the clear identification of factors that may im-pede ability to define true need: there is a need to system-atically identify and document the nonmedical factors(e.g., economic, social, competing needs, bias, and atti-tudes) that influence the ability to conduct an accurateneeds assessment with respect to organ transplantation orthe prevalence/incidence and treatment of end-stage or-gan failure itself.

An International Registry for OrganTransplantation

To appreciate the international scope of challenges fac-ing organ transplantation, an international registry of trans-plantation need using common definitions and metricsshould be established. The development of common metricsrelating to organ transplantation, and the reporting of thesedata to a central international registry, is intended to enrichcurrently available international data, and to harmonize re-porting practices so as to permit a more cohesive global un-derstanding of needs for organ transplantation. Generalpoints:

a. Uniform data based on the true incidence of condition(s)should be forthcoming on an annual basis from each country.

b. The documentation of the availability of organ replace-ment therapies should serve as a measure of “other re-sources” available but should not be used to define need.Comparison between countries who do and do not havesupportive therapies available [e.g., dialysis and left ven-tricle assist device (LVAD)] should be of value.

c. Mortality and morbidity statistics should be used to esti-mate theoretical needs for organ transplantation.

d. Supplementary data from population-based, prospective,or cross-sectional studies, or from other cohort studies,would support the findings from mortality data.

e. A set of useful indicators to inform needs assessmentshould be established in the absence of formal registries oftransplantation need (and to ensure an understanding ofthe continuum of care and health in organ failure).

Key indicators include:

• High-risk conditions (incidence and prevalence) leading toorgan failure;

• Organ failure (all age groups/all organs);• Outcomes of patients with respect to

- movement through stages of diseases (complex)—riskfactors, early identification, end-stage organ failure, andreplacement;

- dynamic nature of chronic conditions adds complexityto data capture;

• individuals who have received organ replacement therapy,for example, the location of therapy delivered (inside vs.outside country);

• variability between and within regions with regards to- Acceptance criteria to organ replacement therapy,- Attitudes/nonmedical factors determining uptake of

various therapies.

• Economic factors driving resource availability (equipment/facilities).

International Data RequirementsIt is imperative that we are able to identify needs-

related data that are relevant (to the pursuit of self-sufficiencyat a national level) and thus would ask that the followinginformation be available to all:

a. By country, and as appropriate by region:• Prevalence and incidence of end-stage organ failure,• Prevalence and incidence of particular diseases contrib-

uting to end-stage organ failure,• Availability of treatment for organ failure (transplant

and non-transplant);

b. Waiting lists have different purposes and start times; thus,it would be of value to determine “true” wait times fororgan replacement therapy (especially organ transplanta-tion therapy);

c. Wait lists keep growing because patients are not taken offdespite being obviously unsuitable for transplantation,which needs to be recognized and factored in;

d. A uniform method of tracking chronic organ failurewould be of value, specifically a uniform tracking of keytime points in the trajectory of disease;

e. Data relating to the identification of organ dysfunctionand the progression of organ dysfunction;

f. Referral to organ replacement therapy (includes assist de-vices, and transplantation);

g. Time for workup, time to acceptance onto waiting list(living donor or deceased as applicable), and time to re-ceipt of organ.

In the context of international data comparisons, it isalso relevant to consider: (1) what methods of successfulneeds prevention currently exist in the different regions? (2)Does the presence or absence of formal structures impact onthe availability of data or resources? Any programme thataims to prevent end-stage organ failure will directly impacton the population need for transplantation, as needs will befavorably affected by the success of such programmes. Imple-mentation of early detection and prevention programmesalso strengthen data collection efforts and hence would makepossible a more accurate assessment of the affected popula-tion. The need for prevention is more acute in countries withlimited resources (though organ replacement therapy is ex-pensive everywhere). This would need support from thehealth policy makers.

With respect to current international preventionstrategies:

• Need to recognize the existence of such programmes, theirscope, implementation methodology, and success. Exam-ples include those among the Aboriginal population inAustralia, Dharan (Nepal), and Chennai (India). Othersmay also exist in South America and Africa, but formaldocumentation of these need to be undertaken.

• There is a need to document variability across regions.• To impress the planners, metric needs to be developed that

would enable the estimation of the projected cost savingsfrom prevention programmes.

The current state of data availability around theworld should form phase 1 of the international assessmentof transplantation needs, collated as an “information avail-



ability world map,” which documents the availability ornon-availability of data on the indicators described earlier.This map would inform an understanding the “gaps” in“needs assessment” itself. (Note that the ideal sourceof these data would be national/regional registries, butother sources, such as smaller cross-sectional studies andrepresentative population cohorts also have utility for thispurpose.)

Metrics or Milestones: How Do We Know We Are GettingThere?a. Create world map describing the current state with re-

gards to ability to capture any data concerning the needfor transplantation. This will allow benchmarking of thecurrent state and methods of data monitoring and surveil-lance abilities for reporting change/improvements. Thismap may be used to:• Determine change by updating the map on an annual

basis;• Identify areas of particular need.

b. Road map/process, by which increasing data collectionwill inform transplantation needs worldwide, should beconstructed:• Describing key elements of need assessment in hierar-

chal manner (information that will be pivotal in inform-ing change);

• Acknowledging regional variation in timelines to achievethis;

• Acknowledging strategies that foster international col-laboration (in data collection, dissemination, and pos-sibly transplantation process itself).

c. Showcase examples of successful meeting of needs fortransplantation do exist, for example, Iceland. Such ex-amples may be considered as case studies and reviewed forelements that exist within that community that have en-abled it to achieve its current state; use as a benchmarkagainst which to map the progress of other countriesbased on key indicators.

d. Compare and contrast elements in each of the differentsituations of organ transplant success (excellent, moder-ate, and poor), so as to confirm the importance of each ofthe elements required for “needs assessment.”

Responding to the Challenges of TransplantationNeeds Assessment

ChallengesThere are a set of recognized challenges to the imple-

mentation of these goals which include, but are not limited to:

a. A lack of clear definition as to who or what or when orwhere the responsibility for needs assessment (data col-lection and dissemination) lies within regions andcountries.

b. Competing needs in different regions or countries per-taining to the “human condition.” In those countrieswhere infection, infant mortality, poverty, war, andstarvation are key concerns on a day-to-day basis, organtransplantation needs must be regarded within the con-text of existing health and social priorities. At the sametime, the framework by which achievements in organ

transplantation are assessed should be adaptable to allcontexts, reflecting differing realities with respect tohealth system development and competing publichealth priorities and thus empowering the stepwisedevelopment of organ donation and transplantationsystems in all nations, commensurate with the pace ofdevelopment.

c. Large variability across and within regions in theirwillingness to invest or allocate resources to informa-tion collection and a systematic approach to needsassessment.

d. The fact that, despite the proposed need for uniformityof definitions and essential data elements across re-gions, this has not yet been achieved even in the devel-oped world where data are more easily obtained andgreater resources exist with respect to registries and datacollection tools.

e. A paucity of human resources (trained medical andother professionals) to assist in all aspects of needs as-sessment and treatment of organ failure— be it care,documentation, evaluation, and implementation.

f. Difficulties in facilitating collaboration between variousstakeholders in the pursuit of common goals withincountries or regions because of political, economic, orother barriers.

g. There is a need to identify opportunities for interre-gional or national collaborations where local resourceswould not support an independent programme. Thiswould lead to improved outcomes and standardizationof processes. It is recognized that given the diversity ofinternational issues, these collaborations may vary overtime, organ types, and situations.

ResponsesGiven the challenges above, the following responses are

suggested:

a. Each country or region should have the ability to:• Assess the incidence and prevalence of conditions that

may lead to end-stage organ failure or the need for organreplacement therapy (transplantation), noting thatprevalence is confounded by availability of therapies/survival outcomes/competing risks and is also relevantas a proxy indicator of need;

• Assess the ability to accurately project progression ofdiseases and predict future incidence and prevalence ofend-stage organ failure (future needs);

• Assess the ability to deliver treatments to delay or pre-vent conditions that lead to need for transplantation(management of current and future needs);

• Describe the nature and performance of current struc-tures and organizations (or lack thereof) responsible foraddressing the need for organs for transplantation(transplantation rates and waiting lists);

• Describe accurately outcomes of patients with organdysfunction/failure/transplanted and non-transplanted.

b. Current state assessment:• It is important to acknowledge the variability of the ca-

pacity of individual countries or regions to identify thosein need;


• It is important to recognize the diversity of resourcesavailable across the world and that strategies for increas-ing organ donation rates will vary depending on thoseresources;

• The need for transplantation (vis a vis “other replace-ment therapies”) may differ in different parts of theworld depending on:- patient demographics (e.g., need may be greater in

countries where patients are younger or there is largepopulation growth, or higher life expectancy),

- availability of complimentary adjunct therapies fororgan dysfunction,

- availability of human and physical resources (trainedprofessionals medical and nonmedical).

c. Unanswered questions:• Does the legal framework of a country impact need as-

sessment? For example, a country may not have a legalframework that permits donation from deceased per-sons. This will change the assessment with respect to theachievability of organ donation from all appropriatesources.

Recommendations and SolutionsThe following set of solutions and recommendations is

defined according to organization/stakeholder. Note thateach stakeholder is important to the process and the successof the strategy.

Governments should:

1. Support identification of organ failure/replacementneeds as a priority for public health improvement.

2. Create a registry for conditions leading to the need fororgan transplantation (all organs and all ages).

3. Invest in prevention programmes as the strategy to re-duce needs (requires identification of at risk and earlydisease patients).

4. Ensure the equity principle is applied in need assess-ment (irrespective of access and resources).

5. Create or support infrastructure and allotment of resourcesfor all aspects of need assessment (human and tools).

The WHO should:

1. Identify as a resolution in the WHA that all countriesshall have the ability to assess their needs for transplan-tation by 2020 (which would include the capacity fordata collection and information sharing).

2. Identify and outline the need for use a core minimumdataset by which international comparisons will be-come meaningful (Table 1).

Professional societies and their members (healthcareproviders) should:

1. Ensure consistent definitions and use of terms in datacollection.

2. Support identification of organ failure/dysfunction as astrategic priority for the organization (for instance inresearch, core mission, and advocacy).

3. Foster international cooperation and intrasocietal co-operation to ensure that data are available for the pur-pose of the evaluation of transplantation needs.

4. Promote and support education about needs assess-ment issues (methods, importance, and application).

5. Promote scientific enquiry in the area of needs assess-ment (validation).

6. Ensure linkages with governmental agencies and policy mak-ers (translational research: bench to bedside to policy).

Patient groups should:

1. Be involved in public health initiatives and policy.2. Be involved in educational programmes for peers/fam-

TABLE 1. Draft template for the assessment of needs for transplantation

Stages: potential toactual needs

Assessment of potential needs(data requirements)

Tools for assessment(mechanisms) Action/purpose (results)

Stage 1: diseasescontributing to organfailure

Estimation of disease prevalenceand incidence

Population studies Identification of opportunities forprevention

Chronic disease assessment Registries Future planning to ensure needsare metCoexistence of multiple diseases

(potential needs)Cohort studies

Stage 2: organ failure/health conditionsrequiring organreplacement therapy

Identification of patients withorgan failure/dysfunction

Education of primary healthcareprofessionals

Early intervention to manageorgan failure and delay needsfor transplantation

Reporting Planning for future management

Stage 3: end-stage organfailure

Identification of transplantationcandidates (actual needsa)

Wait-listing/registeringcandidates

Transplantation

Identification of those unsuitablefor transplantation

Referral to appropriate specialists Provision of alternate therapies

Stage 4: transplantation Registration of transplantrecipients

Routine follow-up andmonitoring of outcomes

Analysis of success in meetingneeds, preventing needs,measuring benefits torecipients, etc.

a The accuracy of the measurement of “actual needs” will be influenced by numerous factors. We suggest mechanisms for monitoring accuracy, for example,through auditing of provinces and comparisons with national data, be developed in conjunction with other data requirements for this enterprise.



ilies and society to ensure value of registration and datacollection well understood by all.

WORKING GROUP 2: SYSTEMREQUIREMENTS FOR THE PURSUIT OF

SELF-SUFFICIENCYLeaders: Ahn Curie, Martin Alejandro Torres, and

Jose Ramon NunezMembers: Maria Joao Aguiar, Mirela Busic, Jose Luis

Di Fabio, Peter Doyle, Mohamed Hilal, Marie Odile Ott,Ferenc Perner, R.K. Srivastava, Zoltan Szabo, Annika Ti-bell, Liu Yong Feng, and Kimberly Young

Essential Requirements and Key Functions ofOrgan Donation and Transplant Systems

To achieve self-sufficiency, it is necessary to both min-imize the need for transplantation and maximize the utility ofavailable resources through efficient organ procurement,successful transplantation, and optimal graft survival. Thisrequires a number of specific systems, structural, organiza-tional, and regulatory developments (Fig. 6).

Essential requirements for system development:

• Government support,• Appropriate legislative, regulatory, and ethical frame-

works,• Adequate healthcare infrastructure,• Adequate resources for programmes, including the long-

term care of patients,• Independent oversight,• Share knowledge and experience with other system models.

Key responsibilities of organ donation and transplantationsystems:

• Organ procurement,• Establishment and maintenance of a transplant recipient

waiting list,• Allocation of organs,• Exchange and transportation of organs both nationally and

internationally,• Approval of transplant teams and institutions,• Safety and quality standards for organs,

• Traceability of all organs,• Monitoring and auditing of transplantation procedures,

using a transplant registry,• Education of health professionals and the general public

about transplantation and the importance of organ dona-tion, including media engagement.

Essential organizational structures:

• NTO,• Hospital transplantation programmes,• OPOs,• An allocation system,• Traceability and surveillance systems,• Data registries.

System Requirements

Legislative and Regulatory FrameworksClear legislative and regulatory frameworks are an essen-

tial system requirement to ensure ethical and transparentpractices in organ procurement, retrieval, allocation, andtransplantation. Specific requirements are as follows:

a. Legislation: clear definition of brain death and circulatorydeath is necessary to enable donation from deceased per-sons, together with legislation governing the procurementand transparent allocation of organs and the establish-ment of OPOs. Legislation should also cover preventionof organ trafficking and commercialism and formal pro-cedures for consenting donors. Critical areas for legisla-tion are:• Declaration of death;• Organ procurement (deceased and living);• Fair and transparent allocation principles;• Consent;• Establishment of transparent organizations;• Prohibition of organ trafficking and commercialism.

b. Regulation and oversight: regulatory bodies are needed tomonitor practices, standards, and outcomes of organ do-nation and transplantation programmes and, therefore,must be informed by comprehensive surveillance anddata collection. Regulatory oversight should guide ethical

Key Points • Legislation must cover death declaration, consent, procurement, and allocation and must govern organ donation and transplantation

practice in accordance with the WHO Guiding Principles. • Regulatory bodies must establish ethically proper organ procurement and allocation processes, review existing practices, and

standardize procedures and oversee performance. • Proper legislation and regulation enhance progress toward self-sufficiency and enable policy making for improved organ donation;

for example, countries may adopt “presumed consent” or “required request” by legislative/regulatory processes. • National Transplant Organizations should be the highest authority in organ transplantation, responsible for maintaining transparency

of programmes, monitoring and surveillance, policy setting and innovation to increase the donor pool; for example, utilization of expanded criteria donors and donation after circulatory death.

• Organ Procurement Organizations may enhance progress toward self-sufficiency by optimizing processes in the identification and management of potential donors: for example, critical pathways, education, death audits, mandatory reporting of potential donors, quality management, and coordination.

• Effective coordination of local, regional, and national systems involved in organ donation and transplantation is fundamental. Each country that performs transplantation requires a unified national coordination network that supports the entire system, through the oversight and regulation of organ distribution, transport, waiting lists, information dissemination, and policy implementation.


standards, development of policy, and quality manage-ment. Essential areas for regulation and oversight include:• Organ procurement procedures;• Development of new policies and introduction of new

procedures;• Reimbursement policies;• Eligibility of living donors and consent processes;• Quality assurance systems (control/audit and profes-

sional education and training);• Allocation rules.

Key National, Provincial, or Regional Organizations

a. The NTO: the NTO must have regulatory functions andprovide oversight to all activities in organ donation andtransplantation. They may also be responsible for themanagement of waiting lists, matching, and allocationand the maintenance of comprehensive registries thatenable collation and analysis of data concerning the cur-rent status of organ donation, transplantation, and graftsurvival, to monitor trends, evaluate performance, andinform policy (see also Working Group 4).

b. OPOs: the functions of the OPO include surveillance todetect potential donors, donor management (medicalmanagement before and after brain death), and pro-curement of organs (including donor assessment, as-certainment of consent, support to donor families,clinical care of the donor, and liaison with surgicalteams). May be centralized and government led, or beunder non-governmental authority; may be hospital-based OPOs (HOPOs) or independent OPOs (IOPOs).IOPOs operate outside the hospital setting and provideservices to multiple transplant centers.

c. National donation promotion programmes: governmen-tal and NGOs have an important role in promoting com-munity support for donation after death. This is achievedlargely through public education to increase awareness, byengaging in public relations through the media and by act-ing as a consumer advocate group (see Working Group 6).Donation promotion may also extend to the promotion ofethically acceptable living donor programmes.

Hospital Transplant ProgrammesWell-organized and professional hospital transplant

programmes are essential to self-sufficiency.

a. Hospital transplant programmes require specialist per-sonnel (transplant surgeons, transplantation physicians, an-esthesiologists, and transplantation coordinators) and infra-structure (intensive and high dependency care unit,hemodialysis unit, and transplantation laboratory).

b. Organ procurement by authorized OPO: the OPO is aseparate organization, which may operate within the hos-pital’s transplant center or outside the hospital setting.

c. A centralized hospital transplantation management team: re-sponsible for regulation and oversight, encompassing a braindeath determination team, the hospital ethical committee,and centralized oversight of education and quality control.

d. Hospital efforts to expand the donor pool: evidence-basedstrategies for enhanced organ availability and utilizationshould be pursued as appropriate, including expandedcriteria donors (ECDs), DCD, and desensitization proto-cols (see Working groups 3 and 5).

Coordination SystemsMultiple systems functioning at local, regional, and na-

tional (and sometimes international) levels are involved in organdonation and transplantation, necessitating an overarching sys-tem for coordination. National coordination systems provide asupport agency for the entire organ donation and transplanta-tion system, responsible for organ distribution, transport orga-nization, waiting-list maintenance, information distribution,and any actions that can contribute to improved outcomes. In-ternational coordination facilitates cross-border exchange of or-gans, information, and research and is critical for combatingorgan trafficking and transplant tourism.

System Challenges

a. Challenges for legislation:• Legislation absent or inadequate.

b. Challenges relating to government support for keyorganizations:

FIGURE 6. Flow diagram of system requirements supporting successful organ donation and transplantationprogrammes.



• Lack of NTO,• Lack of control over the system or corruption,• No assessment of national needs or existence of dona-

tion and transplant registries,• Lack of system integration or professional consensus,• Lack of adequate financial support (understanding true

costs associated with diagnosis and treatment is essentialto building the business case for funding)

• Competing governmental or health priorities.

c. Challenges for healthcare systems:• Lack of professional expertise in transplantation medi-

cine and systems management,• Difficulties in identifying potential donors, managing

their care, and procuring organs,• Lack of hospital infrastructures for management of po-

tential donors,• Lack of coordinated in-hospital procurement team,• Inadequate healthcare system/resources/funding,• Inequitable access to health care,• Lack of follow-up of living donors.

d. Challenges relating to public awareness and education:• Poor public knowledge or understanding about dona-

tion and transplantation,• Absence of school education programmes regarding

the importance of organ donation and transplanta-tion,

• Discomfort and inexperience of medical students andprofessionals regarding death diagnosis or transplanta-tion and donation procedures.

e. Challenges for societies:• Lack of public solidarity and trust,• Misconceptions concerning organ donation and

transplantation,• Cultural and religious perceptions or lack of awareness

of brain death and donation,• Negative media attitudes.

Recommendations and Solutions forGovernments

1. Incorporation of donation and transplantation into na-tional health policies as a priority.

2. Investment in basic infrastructure and legislative frame-works required for transplantation.

3. Adoption of WHO Guiding Principles for Human Cell,Tissue, and Organ Transplantation.

4. Creation of necessary systems for regulation andoversight, to ensure transparency and facilitate re-view of progress and implementation of new strate-gies for success.

5. Incorporate education regarding donation and trans-plantation into school curricula and medical education.

6. Support for deceased donation programmes.7. Creation of national registries, responsible for the

maintenance of the transplant waiting list, and the on-going registration of data on deceased and living donoractivity, transplantation activity, transplant outcomes,and follow-up of recipients and donors.

Examples and ReferencesAn expanded report on the system requirements for

self-sufficiency in organ donation and transplantation, withdetailed examples and references is provided in Appendix 1.

WORKING GROUP 3: MEETING NEEDSTHROUGH DONATION

Leaders: Francis Delmonico, Beatriz Domínguez-Gil,and Faissal Shaheen

Members: Carmel J. Abela, Mustafa Al-Mousawi, Vi-sist Dhitavat, Valter Duro, Marina Minina, Elmi Muller,Alessandro Nanni Costa, Howard M. Nathan, KevinO’Connor, Oleg Reznik, John David Rosendale, JacintoSanchez, George Tsoulfas, and Haibo Wang

Special additional contributors to the critical pathwayfor organ donation: Alexander Capron, Jeremy Chapman,Zhonghua Klaus Chen, Leen Coene, Serguei Gautier, JohnGill, Tomonori Hasegawa, Vivekanand Jha, Guenter Kirste,Tong Kiat Kwek, Bernard Loty, Martí Manyalich, RafaelMatesanz, Luc Noel, Gerry O�Callaghan, Rutger Ploeg, ChrisRudge, Ellen Sheehy, Sam D. Shemie, Annika Tibell, Anan-tharaman Vathsala, and Kimberly Young

Organ Donation as a Critical Element in thePursuit of Self-Sufficiency

Countries or jurisdictions should aim to maximize dona-tion from deceased persons, maximize the outcome from eachdeceased donor (organs transplanted per donor), and optimizeresults of transplantation. Countries or jurisdictions should alsoaim to enable transplants from living donors by providing anethical and legal framework and appropriate donor care.

a. Donation from deceased persons is a requirement, be-cause transplantation activity cannot rely only on theliving donors. Both DBD and DCD are to be considered.

b. Donation from living persons is a necessary componentin the pursuit of self-sufficiency.

Challenges and Obstacles to Maximizing OrganDonation Activities

Legislation and Government

• Legislative frameworks concerning transplantationare absent in certain countries. Nine (9%) of 99 coun-tries reporting to the GODT do not have yet a legisla-tive framework for donation and transplantation.Two of the nine countries with no specific legislationon donation and transplantation reported kidney andliver transplantation activity in 2008; (1)

• Regulatory oversight of donation and transplantation activi-ties is also absent in several countries. Of those countries re-porting to the GODT, 15.3% had no official body nor otherdesignated organization overseeing and coordinating dona-tion and transplantation activities at a national level;

• Legislative impediments, such as the prohibition ofDCD or other specific limitations to donation from de-ceased persons (e.g., viral diseases) are contained withinthe legislative frameworks on organ donation and trans-plantation in some countries.

• Inadequate support (including financial support) for dona-tion and transplantation activities in the healthcare agenda.


Public Attitudes and Media

• Cultural and religious barriers;• Misunderstanding of brain death, circulatory death, and

donation procedures.• Public mistrust of the organ donation process;• Social inequities that undermine consent for donation;

populations or certain groups within a given populationwith no access to transplantable organs are reluctant tosupport donation after death;

• Misconceptions by the media and inadequate reportageof the benefits of organ transplantation.

Support From Healthcare Professionals

• A lack or inadequacy of knowledge, understanding, andsupport concerning organ donation and transplantationon the part of healthcare professionals, particularly foridentification and referral of possible donors;

• Intensive care professionals not recognizing or support-ing donation as a part of end of life care;

• Insufficient family care.

Organization and Systems

• Lack of a designated authority to oversee the process ofdonation and transplantation;

• Lack of OPO(s) with appropriately trained personnel;• Lack of the basic infrastructure necessary for develop-

ment of a deceased donation programme in resource-poor environments;

• Limited availability of mechanical ventilation and inten-sive care resources;

• Lack of protocols for the determination of death;• Lack of technical expertise to recover organs from de-

ceased donors;• The availability of DBD may be limited;• Lack of systematic approach to the process of donation from

deceased persons, limiting the ability to realize the potential oforgandonationfromdeceasedpersonsparticularly intermsofthe number of organs transplanted per donor.- Failure to identify or refer potential deceased donors is

to be considered the main limitation.- Other reasons why a potential donor does not become

a utilized donor are specified in Appendix 2.

Recommendations and SolutionsGovernments Should:

1. Create a legislative framework to enable and regulatedonation and transplantation;

2. Eliminate legislative impediments that might constrain themedicine and science of organ donation and transplantation;

3. Provide adequate support (including financial support)for donation and transplantation in the healthcare agenda;

4. Ensure social equality in the access of patients to transplan-tation therapies and in the distribution of organs, whileensuring the transparency of the system;

5. Establish an authority to oversee the process of donationand transplantation. This authority should ensure the de-velopment of a systematic approach to the process of do-nation from deceased persons and be responsible for:

a. The systematic implementation of processes for donationfrom deceased persons, according to local realities with re-spect to legislation, cultural/religious beliefs, and technicalcapability. The Critical Pathway (Fig. 2) is to be consideredageneral frameworkofreferenceforsystematizingthepro-cess of organ donation from deceased persons;

b. Appointment of qualified and trained professionals,including donor coordinators, to take specific re-sponsibilities in every step of the process and be ac-countable for performance;

c. Definition of protocols for each step in the process ofdonation from deceased persons as described in theCritical Pathway, consistent with the local legal frame-work. This would include the timely identification andreferral of possible deceased organ donors to the appro-priate authority or organization. Recommendations inthis regard are provided in Appendix 2.

d. Development of a quality assurance programme, in-cluding a data registry, for a continuous evaluation oforgan donation and transplantation processes. Thisprogramme should estimate the potential of donationfrom deceased persons, evaluate overall performance inthe deceased donation process, identify areas for im-provement, and ascertain factors critical to success ineach step of the deceased donation process, that is:

• Identification and referral

Key Points • Countries should aim to maximize deceased donation, maximize the outcome from each deceased donor (organs transplanted per

donor), and optimize the results of transplantation. • Deceased donation is a requirement, to be complemented by transplants from living donors. Both donation after brain death and

donation after circulatory death are to be considered. • The Critical Pathway for organ donation is to be considered a general framework of reference for systematizing the deceased

donation process. • Governments should: (i) establish legal frameworks that support and regulate the development of the medicine and science of

donation and transplantation, and ensure quality, transparency, and equity of processes; (ii) support donation and transplantation in the health care agenda, allocating adequate financial resources for the development of the required infrastructure, organizational systems, technical expertise, and data registries for ongoing evaluation of programmes, and (iii) promote a culture of donation by engaging with the general public and health professionals to increase awareness and understanding, and to overcome misconceptions and cultural/religious barriers.

• The support of health professionals is critical to efforts to maximize organ recovery and transplantation.

• The WHO has a role in promoting implementation of the critical pathway, monitoring international data for benchmarking, and fostering regional cooperation for efficient organ sharing practices.



• Consent• Evaluation of medical suitability• Donor maintenance• Organ recovery• Organ preservation• Organ transportation to transplant center• Organ transplantation

e. Development of a training programme for those pro-fessionals direct or indirectly involved in the processof donation from deceased persons.

f. Promotionofacultureofdonationbyengagingthegeneralpublic, specific groups (religious leaders, coroners, media,and academics), and healthcare professionals.

The WHO Should:

1. Promote the implementation of the Critical Pathwayand related recommendations.

2. Monitor the collection of relevant data, assess interna-tional performance in donation from deceased personsfor the purposes of benchmarking, and facilitate the ex-change of knowledge and experiences among countries,as described in more detail in Appendix 2.

3. Foster regional cooperation in sharing of organs that pre-serves equity between donor and recipient populations andthe efficient transplantation of otherwise discarded organs.

Healthcare Professionals Should:

1. Support the process of organ donation;2. Identify and refer possible deceased organ donors in a

timely manner; this particularly applies to intensive andemergency care physicians (see Working Group 5);

3. Make every effort to maximize the number of organsrecovered and transplanted;

4. Promote the recovery of organs from DCD.

Donation From Living Persons:

1. Healthcare professionals should present the option ofdonation from living persons to families of individualswith organ failure.

2. The practice of donation from living persons should beconsistent with the principles of Istanbul Declarationon organ trafficking and transplant tourism.

Related Policy References and Guidelines

Steering Committee of the Istanbul Summit. Organ traf-ficking and transplant tourism and commercialism: TheDeclaration of Istanbul. Lancet 2008; 372: 5.Delmonico F; Council of the Transplantation Society. Areport of the Amsterdam Forum on the Care of the LiveKidney Donor: Data and Medical Guidelines. Transplanta-tion 2005; 79(6 suppl): S53.Ethics Committee of the Transplantation Society. The con-sensus statement of the Amsterdam Forum on the Care ofthe Live Kidney Donor. Transplantation 2004; 78: 491.Matesanz R, Dominguez-Gil B. Strategies to optimize de-ceased organ donation. Transplant Rev 2007; 4: 177.Meeting the organ shortage: Current status and strategiesfor improvement of organ donation. A European consen-sus document. Available at: www.coe.int/t/dg3/health/Source/organshortage_en.doc. Accessed on April 15, 2011

Council of Europe. Recommendation Rec(2006)15 of theCommittee of Ministers to member states: On the back-ground, functions and responsibilities of a National Trans-plantation Organization (NTO). Available at: https://wcd.coe.int/wcd/ViewDoc.jsp?id�1062653&Site�COE. Accessedon April 15, 2011.Council of Europe. Recommendation Rec(2006)16 of theCommittee of Ministers to member states: On quality im-provement programmes for organ donation. Available at:https://wcd.coe.int/wcd/ViewDoc.jsp?id�1062721&Site�CM.Accessed on: April 15, 2011.Council of Europe. Recommendation Rec(2005)11 on therole and training of key organ donation professionals (trans-plant “donor coordinators”). Available at: https://wcd.coe.int/wcd/ViewDoc.jsp?id�870643. Accessed on April 15, 2011.Commission of the European Communities. Communicationfrom the Commission: Action plan on Organ Donation andTransplantation (2009–2015): Strengthened Cooperation be-tween Member States. Available at: http://ec.europa.eu/health/ph_threats/human_substance/oc_organs/docs/organs_action_en.pdf. Accessed on April 15, 2011.US organ donation breakthrough collaborative. Avail-able at: http://www.ihi.org/IHI/Topics/Improvement/Improvement Methods/ImprovementStories/OrganDonation BreakthroughCollaborative.htm. Accessed onApril 15, 2011.

REFERENCE1. Organ donation and transplantation: Activities, laws and organization.

2008 Report of the Global Observatory on Donation and Transplantation.World Health Organization and Organizacio’n Nacional de Trasplantes,March 2010. Available at: http://www.transplant-observatory.org/

WORKING GROUP 4: MONITORINGOUTCOMES IN THE PURSUIT OF SELF-

SUFFICIENCYLeaders: John Gil, Axel Rahmel, and Naoshi ShinozakiMembers: Pavel Brezovsky, Mar Carmona, Elisabeth

Coll, Rui Maio, Jean Bosco Ndihokumbayo, Lausevic Mirjana,Arie Oosterlee, Jose Luis Rojas, Shiro Takahara, Andres Val-divieso, and Lori J. West

Data Monitoring in the Pursuit of Self-SufficiencySelf-sufficiency means satisfaction of the transplantation

needs of a given population, using resources obtained fromwithin that population. Importantly, populations may be de-fined by national or regional boundaries. The availability of re-liable data on population needs with respect to transplantation,on the availability of organs from deceased and living donors, onpatient access to transplantation, and on transplantation out-comes is of crucial importance in this framework. Only with thisinformation it is possible to develop and determine the impact ofpolicies and initiatives in the pursuit of self-sufficiency.

Areas of Relevance for Data Collection in theSelf-Sufficiency Framework

Available Infrastructure

a. Intensive care capacity• ICUs, beds, and ventilators

b. Treatment of end-stage disease• Dialysis units and availability of other bridge therapies


www.coe.int/t/dg3/health/Source/organshortage en.doc

www.coe.int/t/dg3/health/Source/organshortage en.doc

https://wcd.coe.int/wcd/ViewDoc.jsp?id=1062653&Site=COE

https://wcd.coe.int/wcd/ViewDoc.jsp?id=1062653&Site=COE

https://wcd.coe.int/wcd/ViewDoc.jsp?id=1062721&Site=CM

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http://www.ihi.org/IHI/Topics/Improvement/ImprovementMethods/ImprovementStories/OrganDonationBreakthroughCollaborative.htm




c. Transplantation services• Transplant units and transplant programmes• Transplant surgeons• Living donor paired exchange, capacity to treat ABO

incompatible and highly sensitized patients

d. Donation services• Coordinators• OPOs

An inventory of infrastructure (material and humanresources) required to support organ donation and transplanta-tion will permit comparisons between countries or regions withsimilar gross domestic product (GDP) and should assist coun-tries or regions in advocating for necessary resources. Sharing ofthis information could facilitate international or regional initia-tives for shared infrastructure developments (i.e., a human leu-kocyte antigen [HLA] laboratory or a training programme).Similarly, a longitudinal assessment of infrastructure over timein a region would help demonstrate the extent to which a coun-try or region is improving. This effort would be advanced by theestablishment of standardized “tiers” of infrastructure, that is,“minimal/essential, desirable, and optimal.”

Health Policies

a. Regulatory oversight• Registration of transplant centers

b. Financing (public/private)c. Recognition and prevention of end-stage organ failured. Transplantation

• Donation and organ recovery

e. Selection of candidates for transplantation• Indications and contraindications for transplantation,

guidelines for transplant referral and acceptance• Legislation governing practice of organ donation after death• Deceased donor organ allocation policies

f. Living donor transplantation• Legislation governing practice of living donor transplantation

Information regarding the existence of legislation and reg-ulatory oversight to ensure safety and the ethical practice of or-

gan donation and transplantation in accordance with interna-tional standards is fundamental to self-sufficiency. An inventoryof health policies governing organ donation and transplant prac-tices would provide useful information regarding the status oforgan donation and transplantation in a given country or region.Furthermore, availability of international standards and policiesgoverning donation and transplantation would facilitate identi-fication of best practice in the pursuit of self-sufficiency.

Need for TransplantationUnderlying diseases, current (and future) demand for a

transplantation (see also Working Group 1)

• Incidence or prevalence of underlying diseases such asHCV and diabetes mellitus (DM; this information couldbe obtained by International Classification of Diseases(ICD) codes, data from pharmaceutical companies re-garding sales and use of specialized therapeutics),

• Use of bridge therapies (e.g., dialysis register, mechani-cal heart support),

• Deaths from end-stage organ failure (renal and non-renal organs) from national death registry,

• Population burden of renal and non-renal end organ failure.

Organ transplantation needs are correlated with the numberof individuals suffering end-stage organ failure. If information ontheincidenceofunderlyingdiseasesisnotavailable,deathratesfromend-stage organ failure might be a more easily accessible parameter.Withthisinformation,thedemandfororgantransplantationcanbeestimated, but perhaps more importantly, areas where preventativestrategies might lead to a reduced need for transplantation can beidentified. Cooperation between NGOs could support informationsharing inthisarea; forexample, there is significantoverlapbetweencardiorenal diseases and diabetes and therefore cooperationbetween NGOs focused on these specific diseases should beencouraged. Kidney transplantation is cost effective in com-parison with dialysis but is still an extremely expensive and re-source-intensive intervention. The cost of caring for patients withend-stage failure of other organs would be useful in advocating forthe investmentofresources inprevention.Thesocietalcosts includ-ing lost wages, taxes, etc. and would also be useful to capture.

Key Points • The pursuit of self-sufficiency is supported by data collection for the purposes of monitoring population needs, organ availability,

access to transplantation, transplantation outcomes, and the broader policy/ regulatory environment and systems supporting organ donation and transplantation programmes.

• In all countries/regions, data should be collected on the following: (i) available infrastructure (hospital and organizational); (ii) regulatory oversight and health policy; (iii) current and likely future needs for transplantation; (iv) access to the waiting list and to transplantation; (v) waiting list outcomes; (vi) travel for transplantation and transplant tourism; (vii) organ donation from deceased persons; (viii) organ donation from living persons; and (ix) outcomes of transplantation (patient and graft survival). In each of these areas, a minimum dataset should be defined, based on common definitions and standard metrics, to facilitate international comparisons, benchmarking, and the identification of key performance indicators.

• Governments should: (i) support national/regional data registries with infrastructure and human resources; (ii) establish responsibility for operation and governance of this registry; (iii) facilitate cooperation between government and NGOs in monitoring outcomes and disseminating information to the scientific community, the public and policy makers; and (iv) use registry data to assess the impact of policy change and inform the need and direction of new legislation and policy.

• Professionals and Professional Societies should: (i) provide content expertise; (ii) cooperate on the consistency of data elements across the continuum of organ failure (i.e., CKD, dialysis,and transplantation); and (ii) facilitate development of an International Data Group for the ongoing collection of data that will empower individual countries and regions in the pursuit of self-sufficiency.

• This International Data Group should: (i) establish standardized definitions/metrics; (ii) provide/help to establish data registries in all countries/regions involved in organ donation and transplantation; (iii) perform international benchmarking and disseminate effective strategies and details of best practice; and (iv) conduct international studies to address specific data deficiencies.



Access to the Waiting List and Transplantation

a. Number of registrations on the waiting list (absolutenumber and per million population)

● Basic demographic data on patients registered on thewaiting list and comparison to population with end-stage organ failure.

b. Derived indicators● Proportion of patients with end-stage organ failure that

are wait listed;● Time to transplantation from any donor source from

outset of end organ failure.

c. Characteristics of transplanted individuals (comparedwith those of general population or, if available, popula-tion with end organ failure).

Patients should have equal access to the waiting list and totransplantation. The criteria for registration on the waiting listshould be transparent and medically based. Documenting com-pliance with agreed guidelines should be prioritized. Comparingpatient groups with an underlying disease in the population withthose registered on the waiting list would allow monitoring ofaccess to the waiting list. In countries or regions where the avail-ability of bridge therapies (i.e., dialysis) and deceased donortransplantation is limited, waiting lists will be a poor indicator ofaccess to transplantation. In these regions, the characteristics oftransplanted individuals in relation to the characteristics of thegeneral population, or the population with end-stage organ fail-ure if these data are available, will provide some indication of thenature of access to transplantation.

Waiting List Outcomes

a. Number of drop outs, deaths, and transplants (deceased/living donors, absolute number/ per million population).

b. Differences in waiting times, preemptive listing, andtime to wait listing.

c. Proportion of preemptive kidney transplants.d. Outcomes for special patient groups (high urgency pa-

tients, highly immunized patients, and children).e. Compliance/deviation from rules governing organ

allocation.

Monitoring longitudinal changes in time to transplan-tation, waiting time until transplantation, and death on thewaiting list reflect both allocation policies and the availabilityof donor organs. The efficacy and fairness of an allocation andtransplant system become especially evident when looking atspecial patient groups experiencing biologic barriers to trans-plantation. Transparent reporting of organ allocation rulesand compliance with such rules is an essential component ofany organ donation and transplant system.

Travel for Transplant, TransplantTourism—Transplantation Outside the Population

a. Occurrences in the population of delisting from thewaiting list without transplantation.

b. Need for post-transplant therapy without registrationof a transplant.

Assessment of transplant tourism activity is an indirectindicator of sufficiency.

Organ Donation

a. Identifying potential DBD and DCD donors in the hos-pital, converting potential donors to actual donors (seealso Working Group 3).

b. Identification of steps in donation process (identifica-tion of potential donors, approach, consent, organ re-covery, utilization, and organ discard).

c. Selection of donors, including risk management.d. Characterization of the donor—part of a meaningful assess-

ment of system performance and transplant outcomes.

Outcome of Transplantation—Patient and Graft Survival

a. Graft survival and patient survivalb. Complications

• Organ function—measured by glomerular filtrationrate for kidney transplant recipients, measures of organfunction in non-renal organs are not defined

• Tumor, infection, etc.

c. Derived: influence of donor characterization, derivedfrom selection of donors (see Organ Donation, part c).

d. Derived: influence of recipient characterization, derivedfrom selection of recipients (see Access to the Waiting Listand Transplantation)

e. Benefit generated by transplantation• Life years from transplant concept• Reducing the need for retransplantation

The available donor organs should be used in an effec-tive way, and optimal allocation policies and recipient man-agement can increase the long-term benefit.

Living Donor Transplantation

a. Access to living donor transplantation• Preemptive living donor transplantation

b. Outcome of living donor transplantation• Living donor follow-up: documentation of policies for do-

nor follow-up; mechanisms to identify negative outcomesin living donors (e.g., end-stage organ failure).

• Recipient follow-up (graft and patient survival): similarto deceased donor transplant follow-up.

In living donor transplantation, not only do the recip-ient outcomes need to be monitored, at least as important isfor donor outcomes to be monitored.

Establishment of Data Systems/Registries:Standardization, Technical And LegalRequirements, and Quality Assurance

Governance and Oversight for the Registry

a. National policies/oversight to ensure adequate data col-lection, data integrity, and security• Objectives of registries have to be defined at a

– National level (national health authorities and nationalmedical societies)


– International level (WHO and international medicalsocieties)

b. Registry steering group/oversight body• Mandate and terms of reference

c. Policies• Access to the data has to be defined on national and on

an international level• Rules for data exchange have to be established

d. Accountability/registry performance• Internal and external audits/performance reporting• Transparency

Clear ownership of the data, including the rights on re-porting combined with established data privacy measures, is notonly a legal obligation in most countries but are also mandatoryto establish and maintain trust in the system. Ongoing assess-ment of registry performance is necessary to ensure transpar-ency, compliance with governing principles, and the attainmentof objectives.

Structure of Registries, Organization of Data Delivery toor Collection by Registry, and Quality Assurance

a. Responsibility for data delivery/acquisition has to beclearly assigned.

b. Multiple methods of data delivery (based on local infra-structure and needs).

c. Secure data transfer consistent with national data pro-tection regulations.

d. Quality and timeliness of the data has to be assured,reinforced by auditing processes.

e. Standardized registry maintenance policies have to be inplace.

Data Elements

a. Identification of essential data elements• Harmonization with existing national and international

registries

b. Modular system with different tiers of data with increas-ing complexity (required vs. optional data elements, ad-aptation to national needs and capabilities)• Age appropriate data elements have to be included (rec-

ognizing pediatric patients)

c. Identification of derived key performance indicators withcorresponding metrics for benchmarking.

Individual data elements need to be defined taking intoaccount the availability of the data and the purpose to beachieved by collecting this information. The set of relevant andmeasurable factors may be different in the developing and thedeveloped world. A comparison between countries (bench-marking) will only be possible if common definitions are used.

Financing of the Registry

a. Financing of the registry has to be established by nationalhealth authorities• Maintenance of the registry

• Data collection and delivery to the registry (directly orindirectly)

• Data analyses, reporting

b. National and regional registries contribution to an inter-national registry should be free of charge.

Recommendations and SolutionsOverarching recommendations:

1. In all countries or regions data should be collected on the needfor transplantation/burden of end-stage organ disease.

2. In all countries, whether or not there is an existing transplantprogramme, information on (the potential for) organ dona-tion from deceased persons should be collected.

3. In countries with existing transplant activities, data onwaiting lists, transplantation activities, and transplant out-comes should be registered.

4. In each of these areas, a minimum dataset with commondefinitions, allowing international comparisons and in-formation exchange, should be defined.

5. The minimum dataset shall include standard methods/metrics by which to measure the sufficiency of organ transplantprogrammes and identify the key performance indicators rele-vanttomonitorprogresstowardsself-sufficiency.Theseinclude:a. Need for transplantation,b. Organ donation (deceased/living),c. Access to transplantation,d. Outcome of transplantation,e. Transplant tourism.

Governments should:

1. Support the development and operation of nationalor regional registries. This includes investment devel-opment of infrastructure and human resources.

2. Establish responsibility for the operation and gover-nance of the national or regional registry.

3. Ensure cooperation between bodies responsible forclinical care and those in charge of the registry.

4. Support national or regional registry participation ininternational data initiatives.

5. Facilitate cooperation between government agenciesand NGOs to avoid duplication of efforts and promotethe sharing of resources and data.

6. Ensure information is accessible by all stakeholders (scien-tific community, public, and policy makers). Reportinghas to be adapted for each of these groups, with the com-mon aim of uniting the lay public, engaging policy makers,and improving scientific knowledge.

7. Ensure data acquisition to assess impact of policy change andinform the need and direction of new legislation or policy.

8. Facilitate the development of an International DataGroup for the ongoing collection of data that will em-power individual countries and regions in the pursuit ofself-sufficiency.

Professional societies should:

1. Provide content expertise necessary to support collec-tion of national and international data relevant to thepursuit of self-sufficiency.



2. Cooperate to ensure consistency of data elements acrossthe continuum of organ failure [i.e., chronic kidney dis-ease (CKD), dialysis, and transplantation].

3. Advocate for appropriate national or regionalinfrastructure.

4. Support development of national or regional policies.5. Facilitate development of an International Data Group

for the ongoing collection of data that will empowerindividual countries and regions in the pursuit ofself-sufficiency.

Recommendations for an International Data Group:

1. Establish standardized definitions or metrics.2. Define “tiers” of data.3. Provide/help to establish data registries in all coun-

tries/regions involved in organ donation and trans-plantation.

4. Showcase international success stories and disseminateeffective strategies and details of best practice relating toorgan donation and transplantation.

5. Organize and conduct international studies to addressspecific data deficiencies.

6. Publish global information and international compari-sons relevant to the aim of sufficiency.

7. Facilitate cooperation between international NGOs.8. Support national/regional efforts to achieve self-sufficiency.

Patient groups should:

1. Lobby policy makers for necessary resources.2. Ensure common messages are being delivered to the lay

public and policy makers.3. Ensure patient need is the primary consideration of pol-

icies and legislation.

Examples and References

Demand for Transplantation and Access toTransplantation

ERA-EDTA Registry Annual Report 2007. Academic Med-ical Center, Department of Medical Informatics, Amster-dam, The Netherlands, 2009.Cusumano AM, Gonzalez Bedat MC. Chronic kidney dis-ease in Latin America: Time to improve screening and de-tection. Clin J Am Soc Nephrol 2008; 3: 594.Zoccali C, Kramer A, Jager K. The databases: renal replace-ment therapy since 1989-the European Renal Associationand European Dialysis and Transplant Association (ERA-EDTA). Clin J Am Soc Nephrol 2009; 4(suppl 1): S18.White SL, Chadban SJ, Jan S, et al. How can we achieveglobal equity in provision of renal replacement therapy?WHO Bull 2008; 86: 229.Woodle ES, Gupta M, Buell JF, et al. Prostate cancer priorto solid organ transplantation: The Israel Penn Interna-tional Transplant Tumor Registry Experience. TransplantProc 2005; 37: 958.Neil N, Walker DR, Sesso R, et al. Gaining efficiencies: Re-sources and demand for dialysis around the globe. ValueHealth 2009; 12: 73.Zielinski T, Browarek A, Zembala M, et al; on behalf ofPOLKARD HF investigators. Risk stratification of patientswith severe heart failure awaiting heart transplantation:

Prospective National Registry POLKARD HF. TransplantProc 2009; 41: 3161.Cusumano A, Garcia Garcia G, Di Gioia C, et al; on behalf of theLatin American Registry of Dialysis and Transplantation. TheLatin American Dialysis and Transplantation Registry (RLDT)Annual Report 2004. Ethn Dis 2006; 16(suppl 2): S2.

Organ Donation

Coppen R, Friele RD, Gevers SKM, et al. The impact ofdonor policies in Europe: A steady increase, but not every-where. BMC Health Serv Res 2008; 8: 235.

Transplant Outcome

Burra P, Senzolo M, Adam R, et al. Liver transplantationfor alcoholic liver disease in Europe: A study from theELTR (European Liver Transplant Registry). Am J Trans-plant 2010; 10: 138.Mailey B, Buchberg B, Prendergast C, et al. A disease-based com-parisonof livertransplantationoutcomes.AmSurg2009;75:901.Herlenius G, Wilczek HE, Larsson M, et al. Ten years ofinternational experience with liver transplantation for fa-milial amyloidotic polyneuropathy: Results from the Fa-milial Amyloidotic Polyneuropathy World TransplantRegistry. Transplantation 2004; 77: 64.Gidding HF, Topp L, Middleton M, et al. The epidemiologyof hepatitis C in Australia: Notifications, treatment uptakeand liver transplantations, 1997–2006. J GastroenterolHepatol 2009; 24: 1648.Vathsala A; for the Asian Transplant Registry. Immunosup-pression use in renal transplantation from Asian transplantcenters: A preliminary report from the Asian Transplant Reg-istry. Transplant Proc 2004; 36: 1868.Singhal AK, Sheng X, Drakos SG, et al. Impact of donorcause of death on transplant outcomes: UNOS RegistryAnalysis. Transplant Proc 2009; 41: 3539.Close N, Alejandro R, Hering B, et al; for the CITR Inves-tigators. Second annual analysis of the Collaborative IsletTransplant Registry. Transplant Proc 2007; 39: 179.Gentil Govantes MA, Rodriguez-Benot A, Sola E, et al.Trends in kidney transplantation outcome: The Andalu-sian Kidney Transplant Registry, 1984 –2007. TransplantProc 2009; 41: 1583.

Living Donor Transplantation

Araujo CCV, Balbi E, Pacheco-Moreira LF, et al. Evalua-tion of living donor liver transplantation: Causes for exclu-sion. Transplant Proc 2010; 42: 424.Manauis MN, Pilar KA, Lesaca R, et al. A national programmefor nondirected kidney donation from living unrelated donors:The Philippine experience. Transplant Proc 2008; 40: 2100.

Data Selection

Data Harmonization on Transplantation Activities andOutcomes; Editorial Group for a Global Glossary Geneva,June 7– 8, 2007.


Structure of a Registry

Dickinson DM, Bryant PC, Williams MC, et al. Transplantdata: sources, collection and caveats. Am J Transpl 2004;4(suppl 9): 13Dickinson DM, Dykstra DM, Levine GN, et al. Transplantdata: Sources, collection and research considerations, 2004.Am J Transplant 2005; 5(4 pt 2): 850.Shroff S. Indian Transplant Registry: www.transplantin-dia.com. Transplant Proc 2007; 39: 711.Mahdavi-Mazdeh M, Heidary Rouchi A, Rajolani H, et al.Transplantation Registry in Iran. Transplant Proc 2008; 40: 126.

Aims of a Registry

Coppen R, Friele RD, Gevers SKM, et al. The impact ofdonor policies in Europe: A steady increase, but not ev-erywhere. BMC Health Serv Res 2008; 8: 235.Budiani-Saberi DA, Delmonico FL. Organ trafficking andtransplant tourism: A commentary on the global realities.Am J Transplant 2008; 8: 925.

WORKING GROUP 5: FOSTERINGPROFESSIONAL OWNERSHIP OF SELF-

SUFFICIENCY IN THE EMERGENCYDEPARTMENT AND INTENSIVE CARE UNIT

Leaders: Alexander Capron, Alex Manara, and GerryO’Callaghan

Members: Wahyuningsih Andi, Danica Avsec-Letonija, Gabriel Danovitch, Francisco Del Rio, EhtuishEhtuish, Steffen Groth, Niels Grunnet, Anni Kuusvek, TongKiat Kwek, Ko Kyung-Soon, PG Mahipala, Francesco Pro-caccio, and Victor-Gheorghe Zota

The Critical Role of Emergency Department andIntensive Care Unit Professionals

Organ donation is a distinct, time-critical medical processthat provides individuals with end-stage organ failure access totransplantation and its life saving, and life changing, benefits.Transplant programmes can rely on living-related donors tomeet some of the need for donated kidneys, but self-sufficientdonation programmes require a robust system of donation fromdeceased persons (not only hearts, livers, and lungs but also kid-neys). The majority of deceased donor organs originate in EDsand ICUs, but in most countries currently, organs are obtainedfrom only a small minority of ED and ICU patients who wouldbe potential donors.

For a country (or region) to achieve self-sufficiency in or-gan donation, health professionals (principally physicians andnurses) involved in acute health care need to be aware of theirindispensable role in identifying potential donors, in using theirexpertise in the medical management of these critically ill, dyingpatients in a manner that allows and facilitates donation, and inencouraging the families of these patients to consider donationand supporting them as they do so.

To be successful, organ procurement programmes must,therefore, seek to engage healthcare professionals in planningand executing organ donation in their facilities, especially in EDs

and ICUs. Doctors and nurses need to become aware of theirresponsibilities to the broader community and the relevance oftheir skills to organ donation; further, they must have confidenceto support the delivery of this service. Healthcare professionalswho participate in this work deserve to have their skills and en-deavors recognized by their peers, policy makers, funders, andthe community.

Conditions for Self-Sufficiency

a. ICU and ED doctors and nurses are aware of the needfor organ donation and therefore want to facilitate it;

b. ICU and ED doctors and nurses know how to facilitateorgan donation and have the educational, technical, le-gal, and ethical tools to do so;

c. ICU and ED doctors and nurses are supported by theircolleagues, hospitals, and health authorities in facilitat-ing organ donation;

d. Identified doctors and nurses in EDs and ICUs are rec-ognized as experts in this area and in educating theircolleagues about it;

e. These doctors and nurses are expected to take the lead inenabling their ED or ICU to provide this service, includ-ing appropriate counseling for families.

Goals for Each Country/Region

Barriers to achieving Goals 1 and 2:

• ICU/ED physicians and nurses are not aware of the ex-tent of the need for organs and the crucial role the ICUcan play in meeting that need;

• ICU/ED physicians and nurses do not see organ dona-tion as a part of their responsibility in caring for patients(potential donors) and families;

• ICU/ED physicians and nurses believe that respond-ing to need for organs would represent a conflict ofinterest with their obligations to dying patients;

• ICU/ED physicians are not familiar or comfortable withdetermining death in donors or are not, or do not feel,competent to perform relevant tests;

• Specific resources or expertise are not always available ina timely manner to support the diagnosis of brain death(e.g., cerebral angiography);

• ICU/ED physicians and nurses are not compensated or re-warded for the time spent in facilitating organ donation;

• Limited ICU/ED resources restrict the ability of physi-cians and nurses to be involved in organ donation;

• ICU/ED physicians and nurses face, or believe they willface, difficult ethical and legal issues in caring for poten-tial organ donors;

• Organ procurement staff are not available in a timely fashionto interact with ICU/ED patients and their families;

• The country lacks adequate infrastructure/resources toprocure and use organs for transplantation.

Barriers to achieving Goal 3:

• Cultural factors in a country preclude using techniquesthat work in EDs and ICUs elsewhere;

• Organizational factors (from national to institutionallevel) interfere with importing techniques that work inother EDs and ICUs;


www.transplantindia.com

www.transplantindia.com


• The public does not understand or accept the goals oforgan donation and believes that ethical conflicts existwhen physicians and nurses in EDs and ICUs are in-volved in organ procurement.

Recommendations and SolutionsGovernments should:

1. Developclear legalandethical frameworkstoguideICUandEDprofessionals in the care of potential donors, including:a. Standards for determining death that are enacted by

the legislature and accepted by the public;b. Tests and methods that physicians can readily use to

apply these standards in EDs and ICUs;c. Clear statements, at institutional and governmental

levels, regarding the responsibility of various care pro-viders to donors and recipients.

2. Provide clear and unambiguous guidance from the minis-try of health (and other responsible authorities) and hos-pitals to ensure individual intensivists and ED physiciansand nurses are not vulnerable when aiding organ donationprocesses.

Professional Bodies should:

1. Offer training and guidance for ED and ICU nurses andphysicians on how to identify potential donors, commu-nicate with family, determine death, optimize donor

physiology, and interact with OPO and transplant team.Specifically, this should cover:a. Clear guidance on how treatment decisions are reached

(e.g., for patients with severe neurologic injuries) in thecontext of potential organ donors and on the circula-tory and neurologic criteria for determining death;

b. Clear protocols on how to manage dying process forpatients whose deaths will be determined on circula-tory or neurologic grounds;

c. Clear protocols on the optimization of donor physiol-ogy in brain dead donors to maximize the number oforgans donated and the quality of those organs;

d. Education for nurses and physicians on how to makedonation an understandable and acceptable choice forfamilies of dying patients.

2. Support the development of academic and scientific re-search activity in the emergency and intensive care com-munities to create a professional investment in the bestpractice approaches that emerge.

Hospitals Should:

1. Give local ED and ICU staff “ownership” of solving theproblems and developing protocols for managing thecare of potential donors.

2. Identify individuals within the ICU or ED team who canact as role models or “champions” to increase the profile of

Key Points • The majority of deceased-donor organs originate in EDs and ICUs. Hence the pursuit of self-sufficiency requires ICU and ED doctors

and nurses to: (i) be aware of the need for organ donation and are motivated to facilitate it; (ii) know how to facilitate organ donation and have the educational, technical, legal, and ethical tools to do so; (iii) be supported by their colleagues, hospitals, and health authorities in facilitating organ donation; (iv) have identified doctors and nurses in EDs and ICUs recognized as experts in this area, who take the lead in enabling their ED or ICU to provide this service, including appropriate counselling for families; and (v) be involved in the development of protocols for organ donation within their ICU/ED.

• Goals for each country/region with respect to the pursuit of self-sufficiency in the ED and ICU are that: (i) every death in ICU of a potential donor will lead to a timely decision regarding donation; (ii) every death in an ED of a potential donor will lead to a timely decision regarding donation; (iii) each country will be offered solutions that can be customized to apply to the specific circumstances of its EDs and ICUs.

• Governments should develop clear legal and ethical frameworks to guide ICU and ED professionals in the care of potential donors, including: (i) standards for determining death that are enacted by the legislature and accepted by the public; (ii) tests and methods that physicians can readily use to apply these standards; and (iii) clear statements regarding the responsibility of various care providers to donors and recipients, ensuring individual intensivists and ED physicians are not vulnerable when facilitating organ donation processes.

• National Professional Bodies should: (i) provide clear protocols on how treatment decisions relate to donor status and to alternative (circulatory/respiratory and neurologic) bases for determining death; (ii) provide clear protocols on how to manage dying process for patients whose deaths will be determined on circulatory/respiratory or neurologic grounds, as and on post-death maintenance of body; and (iii) educate nurses and physicians on how to make donation an understandable and acceptable choice for families.

• Hospitals should: (i) facilitate local ED/ICU staff “ownership” of potential donor management; (ii) identify champions of organ donation within the ICU/ED team; (iii) appoint donor coordinators within hospitals to facilitate communications amongst ICU/ED staff, families and transplant authorities; (iv) include the possibility for organ donation in every end-of-life care pathway within the ICU and ED; (v) improve the interface with the local transplant team and responsible national authority; (vi) identify strategies to optimize available resources for the conversion of potential donors to actual donors; and (vii) audit outcomes of the donation process.

Goal 1 Every death in ICU of a potential donor will be preceded by a timely decision regarding donation

Goal 2 Every death in an ED of a potential donor will be preceded by a timely decision regarding donation


organ donation within individual ICUs and EDs and pro-vide education for the team on all relevant issues.

3. Appoint donor coordinators within hospitals to facili-tate communications among ICU/ED staff, bereavedfamilies, and transplantation services.

4. Include the possibility or potential for organ donation in ev-ery end-of-life care pathway within the ICU and ED (Fig. 7).

5. Improve the interface between ICUs/EDs and the localtransplant team and responsible national authority.

6. Identify strategies to minimize the effects of lack of resourceson the conversion of potential donors to actual donors.

7. Audit outcomes of the donation process within eachICU/ED and hospital to allow potential areas for improve-ment to be identified and achievable targets to be set.

Examples and References

Examples of National Guidance on Death Diagnosis

A code of practice for the diagnosis and confirmation ofdeath. Academy of Medical Royal Colleges.The ANZICS Statement on Death and Organ Donation[ed. 3]. Australian and New Zealand Intensive Care Society,2008.

Examples of National Legal/Ethical Guidance on IssuesRelevant to Donation

Legal issues relevant to non-heartbeating organ donation.Welsh Assembly Government Department of Health.Organ and tissue donation after death for transplantation:Guidelines for ethical practice for health professionals.Australian Government National Health and Medical Re-search Council.

Example of Expert Panel Guidance on Diagnosis of Death

Bernat JL, Capron AM, Bleck TP, et al. The circulatory-respiratory determination of death in organ donation. CritCare Med 2010; 38: 972.

Examples of Individual ICU Initiatives to IncreaseDonation by Starting NHBD Schemes

Thomas I, Caborn S, Manara AR. Experiences in thedevelopment of non-heart beating organ donationscheme in a regional neurosciences intensive care unit.Br J Anesth 2008; 100: 820.Akoh JA, Denton MD, Bradshaw SB, et al. Early results of acontrolled non-heart-beating kidney donor programme.Nephrol Dial Transplant 2009; 24: 1992.

Factors Influencing Consent Rates

Simpkin AL, Robertson LC, Barber VS, et al. Modifiablefactors influencing relatives’ decision to offer organ do-nation: Systematic review. BMJ 2009; 338: b991.ACRE Trial Collaborators. Effect of “collaborative re-questing” on consent rate for organ donation: random-ized controlled trial (ACRE trial). BMJ 2009; 339: b3911.Shafer TJ. Improving relatives’ consent to organ donation.BMJ 2009; 338: b701.

Analysis of the Effect of “Presumed Consent”

Kwek TK, Lew TW, Tan HL, et al. The transplantable organshortage in Singapore: Has implementation of presumedconsent to organ donation made a difference? Ann AcadMed Singapore 2009; 38: 346.

WORKING GROUP 6: THE ROLE OFPUBLIC HEALTH AND SOCIETY IN THE

PURSUIT OF SELF-SUFFICIENCYLeaders: Jeremy Chapman, Gregorio Obrador, and

Harjit SinghMembers: Adewale Akinsola, Mohamed Salah Ben

Ammar, Filip Danninger, Roser Deulofeu, Athina Gom-pou, Carl Groth, Valentina Hafner, Gunter Kirste, Alan

Goal 3 Each country will be offered solutions that can be customized to apply to the specific circumstances of its EDs and ICUs

FIGURE 7. Flow chart for decisions regarding patients with severe neurologic injuries (example). ICU, intensive careunit; GW, General Ward; PVS, Permanent Vegetative State.



Leichtman, Beatriz Mahillo, Freda O’Neill, Anna Pavlou,Koenraad Vandewoude, and Kumar Sharma Vijay

The Relationship Between Public Health andSociety and the Pursuit of Self-Sufficiency

Public Health and society are closely interrelated be-cause: (1) the mission of public health is the fulfillment ofsociety’s interest in assuring the conditions in which peo-ple can be healthy; (2) the substance of public health isorganized community efforts aimed at the prevention of diseaseand the promotion of health; and (3) the organizational frame-work of public health encompasses both activities undertakenwithintheformalstructureofgovernmentandtheassociatedeffortsof private and voluntary organizations and individuals (1).

Public health is to play a key role in the pursuit of self-sufficiency by reducing demand through prevention of end-stage organ failure potentially leading to transplantation andby promoting donation among health professionals and thegeneral public. Another contribution of public health isthrough the establishment of a well-developed healthcare sys-tem and transplant programme.

Society must possess the willingness to promote andsupport donation, otherwise there would be no organs totransplant. A second societal contribution to the pursuit ofself-sufficiency is in the form of community funding for do-nation and transplantation through public finance and char-itable sources. Table 2 summarizes the roles of public healthand society in the pursuit of self-sufficiency.

Role of Public Health

Prevention of End-Stage Organ FailureCertain causes of end-stage organ failure potentially

leading to transplantation are amenable to primary, second-ary, and tertiary prevention (Table 3).

NCDs are the global leading cause of death, accounting forapproximately 60% of all deaths in 2005, with 80% of NCD-related deaths occurring in low- and middle-income countries(2). This mortality burden attributable to NCDs is predicted tocontinue to increase rapidly in coming years. Approximately half

of NCD-related deaths are attributable to preventable CVD,DM, cancer, or chronic respiratory disease, with the magnitudeof this disease burden a result of two main factors: (1) changingpatterns of lifestyle-related risk factors—increased levels of ex-posure to tobacco use, unhealthy diets, physical inactivity, andthe harmful use of alcohol—and (2) issues of access to effectiveand equitable healthcare services, most acutely affecting popula-tions of low- and middle-income countries.

These data have important implications. First, NCDs im-pose a heavy burden on socioeconomic development and areclosely associated with poverty. Second, CVD, DM, cancer, andchronic respiratory diseases can lead to end-stage organ failure,potentially requiring transplantation. Primary prevention is ofutmost importance, particularly in the setting of financially con-strained, underdeveloped healthcare systems that are unable tobear the costs and resource requirements of chronic diseasemanagement. WHO has launched the 2008–2013 Action Planfor the global strategy for the prevention and control of non-communicable diseases (3) with the aim of reducing the mainmodifiable risk factors in common for these diseases, specificallyunhealthy diets, lack of exercise, tobacco, and harmful use ofalcohol. Secondary and tertiary prevention are also extremelyimportant to reduce the risk of chronic complications and organfailure potentially leading to transplantation.

There are numerous examples of successful chronicdisease prevention strategies around the world. The KidneyEarly Evaluation programme is a free community screeningprogramme aimed at early detection of CKD among high-riskindividuals, including those with DM, hypertension, andfamily history of DM, hypertension, or CKD. It began in theUnited States and now routinely operates in Australia, Japan,and Mexico (4 –7). Metformin use and lifestyle interventionhave been associated with reduction in the incidence of type 2diabetes of 31% and 58%, respectively, in a US randomizedtrial (8). CVD prevention with a multidrug regimen has beenshown to be cost effective in the developing world (9). It isrecognized that CKD prevention would be most cost -effec-tive as a part of an integrated strategy targeting chronic vas-cular diseases (10). An example of this type of integrated in-

Key Points • Public health is to play a key role in self-sufficiency by reducing demand for transplantation through disease prevention, promotion

of donation among health professionals and the general public, and contributing to effective and well-developed health systems

• The frequency causes of end-stage organ failure (diabetes, hypertension, alcohol abuse, HBV, HCV, CAD, and COPD) must be met by primary, secondary and tertiary prevention. Prevention must address the two principle drivers of this disease burden, (i) lifestyle risk factors – tobacco use, unhealthy diets, physical inactivity, and harmful use of alcohol, and (ii) ineffective and inequitable healthcare services.

• Donation education and promotion, drawing on public health methodologies, is necessary to strengthen public commitment to organ and tissue donation, and increase the willingness of medical professionals to be involved in the donation and transplantation process. Society must have a willingness to promote and support donation, else there would be not organs to transplant.

• The act of donation is itself an individual decision that interacts with the social setting and the institutional and regulatory framework into which an individual is embedded. Family refusal, together with failure to identify potential donors, is the most significant impediment to increase rates of donation. Public education efforts need to counter poor awareness, distrust of medicine and misconceptions about donation and transplantation, while instilling notions of reciprocity, solidarity, and an appreciation of the uniquely life-saving nature of donation.

• In low-income settings, where health sector development constrains the development of organ donation and transplantation, prevention of end-stage organ failure within the context of wider public health goals is crucial to self-sufficiency. Adverse public attitudes and legal restrictions may pose additional obstacles to transplantation, therefore culturally appropriate education and the endorsement of donation and transplantation by community and religious are essential. Service delivery may use both private and non-governmental means of financing, and grow from synergies between governments, NGOs, and charities.


tervention has shown success in rural India, achieving bloodpressure and DM targets, and lowering prevalence of CKD atan annual cost of US $0.43 per capita of population (11). Thisprogramme minimized costs by using nonphysician healthworkers and cheapest available diagnostic tests and drugs.Combination pharmacotherapy, a fixed dose of aspirin, a sta-tin, an angiotensin-converting enzyme inhibitor, and a di-uretic/�-blocker, may also have potential as an integrated ap-proach to chronic vascular disease in low- and middle-income countries (12).

Promotion of DonationPublic health can help to increase organ donation

through education, information, encouragement, and pro-

motion of donation and transplantation among health pro-fessionals and the general public.

Health ProfessionalsMany publications have demonstrated that the willing-

ness of healthcare professionals to participate in the donationprocess can improve the donation rate (13, 14). Donation edu-cation of health professionals, particularly of transplant coordi-nators, emergency and ICU doctors, and family practitioners, iscritical (15). In Spain, transplant coordinators are trained asmanagers of educational programmes and resources, are re-sponsible for administrative tasks, and are also in charge of me-dia relations (16). There are also reports of donation educationfor medical students as a way to enhance the link between phy-sicians and procurement professionals (17–20).

Because nurses are usually the first people among thehealthcare staff to recognize a patient as a potential donor,they have an important role in the procurement of organand tissue from deceased donors. Educational pro-grammes can enhance nurses’ knowledge and commit-ment to the organ donation process and, ultimately, in-crease the donation rate. In a recent report from Pakistan,knowledge and attitudes toward organ and tissue donationimproved significantly after nurses attended a 1-day work-shop on organ donation (21). Consequently, it is of greatimportance for OPOs to offer regular training pro-grammes for all their healthcare staff (22).

General PublicPublic attitudes to and awareness of organ donation and

transplantation are key elements affecting donation rates. Publichealth methodology applied to donation education pro-grammes consists of assessing the status of donation-relatedpublic education, identifying existing needs in donation educa-tion by applying principles learned from other public health ed-ucation programmes, and identifying roles than can be assumedto help strengthen the public’s commitment to organ and tissuedonation (23). A systematic review of the literature yielded eightelements of effectiveness that could be used to assess donationeducation efforts (23). They are the use of:

• Formative research,• Strategic planning,• Appropriate messages,• Audience-based strategies,• Multiple channels,• Collaboration with other groups in a community,• Evaluation, and• Coordination of information exchange in the transplant

field.

Oberley (24) examined barriers to donation and as-sessed educational materials and programmes, concludingthat grassroots, community-based programmes were essen-tial to supplement mass media efforts and that well-re-searched campaigns, targeted to specific audiences, were alsokey to success.

Challenges and Recommendations for Public Health inthe Pursuit of Self-Sufficiency

It is important to note that sustainability of publichealth programmes is driven by the critical processes of sys-

TABLE 2. Roles of public health and society in thepursuit of self-sufficiency

Public health Screening and prevention of end-stage organfailure potentially leading to transplantation

Promotion of donation among healthprofessionals and the general public- Skills and knowledge development

among health professionals- Promotion of trust in organ donation

throughout the communityDevelopment of efficient healthcare systems

and transplant programmes- Development of efficient donor

procurement organizations- Develop society and medically acceptable

recipient selection and organ allocationsystems for deceased donortransplantation

- Optimize accredited transplant programmes- Ensure transparency in support of equity- Ensure maintenance of safety and quality of

donation and transplantation- Create national programmes but implement

them locally

Society Willingness to promote and support organdonation

Community funding through public financeand charitable sources

TABLE 3. Frequent causes of end-stage organ failureand common risk factors

End-stageorgan failure Frequent causes

Common riskfactors

Kidney failure Diabetes hypertension Unhealthy diet

Liver failure Alcohol abuse Lack of exercise

Hepatitis B virus Tobacco use

Hepatitis C virus Harmful use ofalcohol

Heart failure Coronary arterydisease

Intravenousdrug abuse

Hypertension

Lung failure Chronic obstructivepulmonary disease



temization and standardization. In particular, improving sus-tainability may require stabilization of organizational re-sources, attention to incentives, and standardization ofpolicies at the national level (25). The Working Groupidentified several barriers to public health efforts in thepursuit self-sufficiency and provided some solutions andrecommendations (Table 4).

Role of SocietyThe act of donation is in itself an individual decision

that requires a depth of understanding that interacts with thesocial setting and the institutional and regulatory frameworkinto which an individual is embedded. Decisions are influ-enced by regulation (presumed consent), awareness of regu-lation, and social interactions, such as the ability to count onothers in case of a serious problem, also known as reciprocity(26). Other factors, such as age, race, education, socioeco-nomic status, and religion, among others, determine willing-ness to donate one’s own organs and consent to the donationof those of a relative (27).

Donors, Recipients, and Their FamiliesIn any society, individuals’ and families’ attitudes

toward donation are critical factors in self-sufficiency.Families’ refusal of organ donation, together with failureto identify donors, remain the most important impedi-ments to improve rates of organ donation from deceasedpersons in most high-income countries. In a study thatcompared donor and nondonor families, donation wasmore likely when the deceased had made his or her dona-tion intentions known and the next-of-kin had more fa-vorable organ donation beliefs, but was less likely whenfamily members were not in complete agreement aboutdonation (28). These findings highlight the need for con-tinued public education efforts to maximize positive be-liefs about organ donation and promote the necessity ofsharing donation intentions with others (29, 30).

Little is known about how best to educate patients andtheir families about donation from living persons. In a studyof living donor kidney transplantation (LDKT), patients wererandomized to receive clinic-based (CB) education alone orCB and home-based (CB�HB) education (31). The latterinvolved home visits with the patient, family, and other po-tential donors by one or two trained health educators. Whencompared with CB, more patients in the CB�HB group hadliving donor inquiries, evaluations and LDKTs (30.4% vs.52.4%, P�0.013). Both groups demonstrated an increasedLDKT knowledge after the CB education, but CB�HB led toan additional increase in LDKT knowledge and in willing-ness to discuss LDKT with others and a decrease in LDKTconcerns.

The Wider CommunityThe messages delivered by public education efforts

must be clear, well defined, positive, and essentially shared byall those involved in the process of organ donation and trans-plantation. A Spanish multiethnic national survey docu-mented a significant relationship between the degree to whichthe public is prepared to accept organ donation, and the con-viction that transplantation is a good and positive element ofhealth care (32). The mass media can be both useful in pro-

moting, but also risks adversely affecting, organ donation(29, 33). Managing adverse publicity is a complex and time-consuming task that must be combined with adequate andsystematic spread of the positive and life-enhancing aspects oforgan donation and transplantation. Success depends notonly on provision of adequate information to the public butalso on the transparency of donation and transplantationsystems. Direct publicity campaigns are not guaranteed topositively influence the attitude of the public toward organdonation and are costly. One cost-effective strategy is thatused by the Spanish Model, in which ONT provides infor-mation to the public and the media by means of a 24-hrtransplantation hotline and periodic meetings with jour-nalists, communication experts, and leaders in trans-plantation. Health professionals, who are responsible foridentifying potential donors and in some cases approach-ing the grieving families, should also be a key target ofeducation efforts (15).

Donation education should also target specific groups,such as religious leaders (27) and school students (34). Al-

TABLE 4. Challenges and recommendations for publichealth in the pursuit of self-sufficiency

Barriers Solutions and recommendations

Prevention of end-stage organ failureLack of or insufficientprogrammes to preventend-stage organ disease

Reduce transplant demand bypreventing end-stage organ failurefrom diabetes, hypertension,cirrhosis of the liver, and chronicpulmonary disease

Ineffective andinequitable care forchronic diseases

Reduce transplant demand by effectiveand equitable care of chronicdiseases, particularly diabetes andhypertension

Promotion of donationInsufficient donationeducation of healthprofessionals

Encourage ICU and Emergency RoomER doctors and residents to assumeresponsibility for organ donation

Education of primary care physicians,nurses, medical students, and otherallied health professionals

Insufficient donationeducation of the generalpublic

Develop culturally sensitive awarenessprogrammes

Use public health methodologyInvolve communication specialists

Efficient healthcare systems and transplant programmesCompeting factors andresource limitations

Use private and non-governmentalsources of funding

Lack of/inadequatetransplant programmesbecause of issues ofinfrastructure,organization, healthsystem financing, legaland ethical regulationof the transplantprocess, and high costof immunosuppressivedrugs

Establish synergies between thegovernment and NGOs/charities(e.g., Sindh Institute of Urologyand Transplantation in Karachi,Pakistan)

International collaboration

ICU, intensive care unit; NGO, non-government organization.


though most clergy are supportive of organ donation, reli-gious objections are often cited as a reason for refusal to giveconsent for donation. School-based education programmesconcerning organ donation and registration of intent to do-nate have been systematically developed in The Netherlandsto enable adolescents to make well-informed decisions aboutorgan donation (37). Also, donation education for Depart-ments of Motor Vehicles clerks, who in several countries serveas gatekeepers to organ donation registration, is an effectiveway to increase knowledge, attitudes, and beliefs among thesekey individuals and may increase donor registration ratesamong the public (38, 39).

Public education concerning organ donation andtransplantation needs to take into account cultural diversity.Promoting organ donation and transplantation in a multicul-tural environment represents one of the major challengesfacing the transplant community (40). Different attitudes,cultures, and values systems mean that a blanket standardapproach to organ shortages will not be effective. Promotionof donation and transplantation should involve a team ofhealthcare workers who are sensitive to the values and thetraditions of individual groups in society, in addition to acoordinated effort to clear any misconceptions about or-gan donation, improve public education and awareness,and promote communication with the general public. Re-spect for cultural diversity and a better understanding ofthe cultural influences involved will build stronger supportfor transplantation and more successful organ donationcampaigns.

Overcoming barriers toward organ donation from de-ceased persons in public opinion is a real challenge. Resis-tance to organ donation after death derives from lack ofawareness, religious uncertainties, distrust of medicine, hos-tility toward new ideas, and misconceptions about organdonation and transplantation. Education should be used toreshape public opinion about the use of organs for transplan-tation (41). To optimize organ donation in any given society,it is important that the community accept that use of bodyparts is moral and offers a source of health for everybody. Theconcept that using deceased donor organs implies sharing asource of health ideally forms a social agreement between allmembers of society. Suggestions for improving organ short-age include (1) developing an understanding that duringone’s life one is more likely to need to be an organ recipientthan an organ donor and (2) cadaver organs are an irreplace-able source of health.

Challenges and Recommendations for Society in thePursuit of Self-Sufficiency

The Working Group identified several challenges forsocieties in the pursuit of self-sufficiency and provided somesolutions and recommendations (Table 5).

Challenges of Underdeveloped HealthcareSystems

Limited per capita health expenditure and underde-veloped health care systems affecting capacity for trans-plantation are important challenges facing organ donationand transplantation in low-and middle-income countries.Additional challenges in these settings may include lowlevels of education, cultural antipathy, and adverse public

attitudes toward organ donation and transplantation. Ad-verse legislation may also be an obstacle in some countries.In Nepal, for example, donation from living persons is onlypermitted from individuals in direct relation to the recip-ient from the paternal side, which has brought about adisparity in number of recipients and donors. Regulationor organ donation from deceased persons is also lacking inthis country.

As in high-income countries, education about organdonation and transplantation is essential to the pursuit ofself-sufficiency. The message that transplantation, as theresult of donation from a living or deceased donor, is themeans by which people suffering from end-stage organfailure may have hope, should be communicated in a cul-turally sensitive way to the general public. The role ofteachers, priests, political and social leaders, and celebri-ties is crucial in achieving this goal. For organ donationafter death, trained counselors are required for educationof potential donors and relatives.

Despite these challenges, there are examples of suc-cessful transplantation programmes in the developingworld, such as the Sindh Institute of Nephrology andTransplantation in Pakistan (42). This model of govern-ment-community partnership receives 40% of its budgetfrom the government and the rest from the community asdonations. The scheme has been extremely successful inproviding free medical care and support for thousands ofpatients. It has been sustained over the past two decades bycomplete transparency, public audit, and accountability.

TABLE 5. Challenges and recommendations forsociety in the pursuit of self-sufficiency

Barriers Solutions and recommendations

Lack of awarenessabout donation

Provide regular and consistent behavioralchange communication programmes

Develop culturally sensitive awarenessprogrammes directed to general public,religious leaders, schools, Department ofMotor Vehicles’ clerks, among others

Cultivate community role models andchampions for organ donation andtransplantation

Provide public recognition to donors andtheir families

Develop a positive attitude about donationthrough mass media, films, TV shows,radio programmes, books, and socialnetworking sites

Adverse publicity Actively manage adverse publicity

Distrust ofmedicine

Provide adequate information andtransparency about all aspects ofdonation and transplantation

Misconceptionsabout donationand transplantation

Develop educational programmes to dispelmyths about donation andtransplantation

Take into account people’s beliefs andvalues and the broader socioculturalcontext in which they live



REFERENCES1. IOM. The Future of Public Health. Committee for the Study of the

Future of Public Health, Division of Health Care Services, Institute ofMedicine. Washington, D.C., National Academy Press 1988.

2. WHO. Preventing chronic diseases: A vital investment: WHO globalreport. Geneva, World Health Organization 2005.

3. WHO. 2008 –2013 action plan for the global strategy for the preventionand control of noncommunicable diseases: prevent and control cardio-vascular diseases, cancers, chronic respiratory diseases and diabetes.Geneva, World Health Organization 2008.

4. Mathew TH, Corso O, Ludlow M, et al. Screening for chronic kidneydisease in Australia: A pilot study in the community and workplace.2010; 77: S9.

5. McCullough PA, Vassalotti JA, Collins AJ, et al. National KidneyFoundation’s Kidney Early Evaluation Program (KEEP) annual datareport 2009: Executive summary. Am J Kidney Dis 2010; 55(3 suppl2): S1.

6. Obrador GT, Garcia-Garcia G, Villa AR, et al. Prevalence of chronickidney disease in the Kidney Early Evaluation Program (KEEP)Mexico and comparison with KEEP US. Kidney Int Suppl 2010;77(S116): S2.

7. Takahashi S, Okada K, Yanai M. The Kidney Early Evaluation Program(KEEP) of Japan: Results from the initial screening period. Kidney IntSuppl 2010; 77(S116): S17.

8. Diabetes Prevention Program Research Group. Reduction in the inci-dence of type 2 diabetes with lifestyle intervention or metformin.N Engl J Med 2002; 346: 393.

9. Gaziano T, Opie L, Weinstein M. Cardiovascular disease preventionwith a multidrug regimen in the developing world: A cost-effectivenessanalysis. Lancet 2006; 368: 679.

10. Dirks JH, de Zeeuw D, Agarwal SK, et al. Prevention of chronic kidneyand vascular disease: Toward global health equity—The Bellagio 2004Declaration. 2005: S1.

11. Mani MK. Nephrologists sans frontieres: Preventing chronic kidneydisease on a shoestring. 2006; 70: 821.

12. Wise J. Polypill holds promise for people with chronic disease. BullWorld Health Organ 2005; 83: 885.

13. Simpkin AL, Robertson LC, Barber VS, et al. Modifiable factors influ-encing relatives’ decision to offer organ donation: Systematic review.BMJ 2009; 338: b991.

14. Andreoni KA: Educating Kidney Transplant Professionals and Candi-dates May Improve Utilization, Allocation Efficiency and Lifetime Sur-vival. Am J Transplant. 10:711–712, 2010.

15. Williams MA, Lipsett PA, Rushton CH, et al. The physician’s role indiscussing organ donation with families. Crit Care Med 2003; 31:1568.

16. Matesanz R. Factors that influence the development of an organ dona-tion program. Transplant Proc 2004; 36: 739.

17. Essman CC, Lebovitz DJ. Donation education for medical students:Enhancing the link between physicians and procurement professionals.Prog Transplant 2005; 15: 124.

18. Feeley TH, Tamburlin J, Vincent DE. An educational intervention onorgan and tissue donation for first-year medical students. Prog Trans-plant 2008; 18: 103.

19. Deulofeu R, Blanca MA, Twose J, et al. Attitudes and knowledge onorgan and tissue procurement and transplantation of emergency andprimary care doctors in Spain. Med Clin 2009; 9: 9.

20. Manyalich M, Paredes D, Balleste C, et al. The PIERDUB project: In-ternational Project on Education and Research in Donation at Univer-sity of Barcelona: Training university students about donation andtransplantation. Transplant Proc 2010; 42: 117.

21. Aghayan HR, Arjmand B, Emami-Razavi SH, et al. Organ donationworkshop—A survey on nurses’ knowledge and attitudes toward organand tissue donation in Iran. Int J Artif Organs 2009; 32: 739.

22. Bener A, El-Shoubaki H, Al-Maslamani Y. Do we need to maximize theknowledge and attitude level of physicians and nurses toward organdonation and transplant? Exp Clin Transplant 2008; 6: 249.

23. Ganikos ML, McNeil C, Braslow JB, et al. A case study in planning forpublic health education: The organ and tissue donation experience.Public Health Rep 1994; 109: 626.

24. Oberley E. Public education in organ and tissue donation: Review andrecommendations. Madison, WI, Medical Media Publishing 1992.

25. Koh HK, Jacobson MD, Lyddy AM, et al. A statewide public healthapproach to improving organ donation: The Massachusetts organ do-nation initiative. Am J Public Health 2007; 97: 30.

26. Rithalia A, McDaid C, Suekarran S, et al. Impact of presumed consentfor organ donation on donation rates: A systematic review. BMJ 2009;338: a3162.

27. Saleem T, Ishaque S, Habib N, et al. Knowledge, attitudes and practicessurvey on organ donation among a selected adult population of Paki-stan. BMC Med Ethics 2009; 10: 5.

28. Rodrigue JR, Cornell DL, Howard RJ. Organ donation decision: Com-parison of donor and nondonor families. Am J Transplant 2006; 6: 190.

29. Krekula LG, Malenicka S, Linder M, et al. From words to action—Influence of two organ donation campaigns on knowledge and formaldecision making. Clin Transplant 2009; 23: 343.

30. Rodrigue JR, Cornell DL, Howard RJ. Relationship of exposure to or-gan donation information to attitudes, beliefs, and donation decisionsof next of kin. Prog Transplant 2009; 19: 173.

31. Rodrigue JR, Cornell DL, Lin JK, et al. Increasing live donor kidneytransplantation: A randomized controlled trial of a home-based edu-cational intervention. Am J Transplant 2007; 7: 394.

32. Martin A. Donacion de organos para trasplante: Aspectos psicosociales.Nefrología 1991; 11: 62.

33. Matesanz R, Miranda B. Organ donation—The role of the media and ofpublic opinion. Nephrol Dial Transplant 1996; 11: 2127.

34. Baughn D, Rodrigue JR, Cornell DL. Intention to register as organdonors: A survey of adolescents. Prog Transplant 2006; 16: 260.

35. Reubsaet A, Brug J, Kitslaar J, et al. The impact and evaluation of twoschool-based interventions on intention to register an organ donationpreference. Health Educ Res 2004; 19: 447.

36. Reubsaet A, Reinaerts EB, Brug J, et al. Process evaluation of a school-based education program about organ donation and registration, andthe intention for continuance. Health Educ Res 2004; 19: 720.

37. Reubsaet A, Brug J, Nijkamp MD, et al. The impact of an organ dona-tion registration information program for high school students in theNetherlands. Soc Sci Med 2005; 60: 1479.

38. Rodrigue JR, Cornell DL, Jackson SI, et al. Are organ donation attitudesand beliefs, empathy, and life orientation related to donor registrationstatus? Prog Transplant 2004; 14: 56.

39. Harrison TR, Morgan SE, Di Corcia MJ. Effects of information, educa-tion, and communication training about organ donation for gatekeep-ers: Clerks at the Department of Motor Vehicles and organ donor reg-istries. Prog Transplant 2008; 18: 301.

40. Oniscu GC, Forsythe JL. An overview of transplantation in culturallydiverse regions. Ann Acad Med Singapore 2009; 38: 365.

41. Cantarovich F. Public opinion and organ donation suggestions forovercoming barriers. Ann Transplant 2005; 10: 22.

42. Rizvi SA, Naqvi SA, Hussain Z, et al. Renal transplantation in develop-ing countries. Kidney Int Suppl 2003; 83: S96.

WORKING GROUP 7: ETHICS OF THEPURSUIT OF SELF-SUFFICIENCY

Leaders: Nikola Biller Andorno, Rudolf Garcia-Gallont, and Farhat Moazam

Members: Linda Ezekiel, Susalit Endang, MiguelAngel Frutos, Sergei Gautier, George Kyriakides, TerenceMangan, Dominique Martin, Geeta Mehta, Fernando RaulMorales Billini, Hans H. Schlitt, McCartney Trevor, DanielWikler, and Gerson Zavalon

Ethical FoundationsSelf-sufficiency is to be understood as a strategic ap-

proach rather than as an ethical imperative. It aims to fosterthe adequate provision of organs and transplantation servicesto meet the needs of a given population, using resources fromwithin that population. Responsibly administrating thescarce and precious resource of human organs for transplan-tation also encompasses actions directed toward the preven-tion of organ failure.


The pursuit of self-sufficiency requires a paradigmshift, from a perception of organ transplantation as a matterof the rights of a donor and a recipient, to one of responsibil-ities at the family, community, national, and internationallevel. It is also important to recognize the profound emo-tional, psychosocial, and experiential components connectedwith the act of donating and receiving an organ, in addition totraditional clinical and biologic concerns.

Ethical Premises

a. The human right to health requires that countries under-take measures to prevent end-stage organ failure, and treatthose suffering from end-stage organ failure through theuse of transplantation where this is appropriate.

b. Organs should be understood as a social resource; equityshould govern both procurement and allocation.

c. Organ donation should be perceived as a civic re-sponsibility toward fellow citizens. Organ marketsand transplant tourism lead to morally unacceptablecoercion and exploitation of the disadvantaged.

Ethical PrinciplesIn accordance with the Declaration of Istanbul (1), self-

sufficiency promotes the following ethical principles:

a. Minimizing harm/reducing suffering: through an em-phasis on the reduction of need for transplants whileaiming to maximize the number of organs available fortransplantation.

b. Justice: by promoting a more equitable distributionof benefit and burden (potential recipients as poten-tial donors and vice versa), and censuring practicesthat involve the exploitation of any party.

c. Respect for persons: by avoiding undue incentives,while appealing to the community-oriented values ofsolidarity and civic responsability.

Self-sufficiency is an aspirational concept, which can beimplemented in different, locally relevant ways, and therefore

progress in the pursuit of self-sufficiency needs to be mea-sured by context-dependent benchmarks. Clearly not em-bracing the pursuit of self-sufficiency would be healthcaresystems that:

• Do not strive to develop capacity to prevent end-stage or-gan failure or provide for the transplantation needs of theirpopulation (where health system development is sufficientto support transplantation programmes);

• “Outsource” transplantation and provision of organs bysending their citizens to other countries;

• Encourage organ sales, domestically or to nationals ofother countries.

Questions and Challenges

a. Will self-sufficiency encourage an insular attitude ratherthan global solidarity?

b. Is self-sufficiency an achievable goal for developingcountries?

c. Potential abuses.

• Organ markets disguised as regional cooperation;• Domestic financial incentives;• Inequitable allocation or lack of transparent waiting list;• Unethical practices in the donation of organs from living

persons.

d. Diversity in cultural approaches to death/deceased per-sons/dead bodies and related implications for attitudes to-ward donation.

e. Lack of awareness and education among public and healthprofessionals.

Recommendations

Recommendations to Health Authorities

1. Acknowledge that the pursuit of self-sufficiency doesnot preclude a collaborative approach, capacity build-ing, or humanitarian assistance;

Key Points • The self-sufficiency paradigm reframes organ transplantation from a matter of the rights of a donor and recipient, to one of

responsibilities at the family, community, national, and international level. This paradigm is based on three main ethical premises: (i) the human right to health means that countries should invest in the prevention of end-stage organ failure and in its treatment through maximizing access to transplantation; (ii) organs are a social resource, the management of which must be transparent and equitable; and (iii) organ donation should be perceived as a civic responsibility, in contrast to organ markets and transplant tourism, which lead to morally unacceptable coercion and exploitation of the disadvantaged.

• The pursuit of self-sufficiency promotes the ethical principles of minimizing harm/reducing suffering, justice, and respect for persons. • Health authorities should: (i) take responsibility for meeting transplant needs and actions to prevent organ failure; (ii) be accountable

for the ethical integrity of the system; and (iii) acknowledge the role for collaborative approaches, capacity building, and humanitarian assistance within the self-sufficiency paradigm.

• Health professionals should: (i) receive training in ethical aspects of organ transplantation; (ii) contribute to the education of the public; (iii) maximize the utilization of donated organs; and (iii) be vigilant concerning unethical/illegal behavior and willing to report it to judicial, professional, and human rights bodies.

• Professional societies should also foster research on questions of culture, values, and ethics as they relate to self-sufficiency. There is also a need for research in particular reference to the nature of the implementation of self-sufficiency to inform unresolved ethical questions.

• Civil society should: (i) establish an ethos of social responsibility and solidarity in meeting transplantation needs through participation in deceased donation; (ii) be sensitive to the needs of both donors recipients; and (iii) engage NGOs, community and faith-based organizations.



2. Take responsibility for meeting transplant needs andactions to prevent organ failure;

3. Be accountable for the ethical integrity of the system.

Recommendations to Professionals

1. Receive training in ethical aspects of organ transplantation;2. Contribute to the education of the public;3. Maximize the utilization of donated organs;4. Be vigilant concerning unethical/illegal behavior and

willing to report it to judicial, professional, and humanrights bodies.

Recommendations to Civil Society

1. Establish an ethos of social responsibility and solidarityin meeting the community’s transplant needs throughparticipation in donation after death;

2. Be sensitive to the needs of both the donor and therecipient;

3. Engage NGOs and community- and faith-basedorganizations.

Recommendations to Scientific and Professional Bodiesand Funding Agencies

1. Foster research on questions such as:

a. How is the pursuit of self-sufficiency consistent withthe values in different cultural and religious contexts?

b. What are cultural, social, and religious obstacles todonation after death, and how might they be over-come?

c. How does the emphasis on organs as a communityresource impact on motivation to participate in pre-vention programmes/donation after death?

d. How to maintain equity within regional cooperationto preserve mutual benefits and avoid an unbalancedflow of organs or other related resources from onecountry to another.

e. What constitutes an equitable donation pattern?

Examples of Ethical Approaches to Challenges inthe Pursuit of Self-Sufficiency

a. Tanzania: because of a lack of transplantation services inTanzania currently, a programme has been arranged toethically and safely match altruistic living-related kid-ney donors to those requiring transplantation. Donorsand their recipient relatives are flown abroad to Indiawhere procurement and transplantation is performed atthe cost of the Tanzanian government, and patientsthen return home for follow-up care. This temporarysolution to the problem of unavailable transplantationservices in Tanzania is highly valued but is neither costeffective nor sustainable in the long term. Therefore,Tanzania is working toward the development of trans-plantation services, so that, in the future, patients anddonors may receive all their care locally, avoiding the needto rely on the services of foreign countries (L. Ezekiel, per-sonal communication).

b. Spain—Portugal exchange for lung transplantation:Portuguese patients have been officially admitted to the

lung transplant waiting list in Spain while transplantteams in Portugal develop technical expertise. This leadto an official agreement between the two countries,whereby the lungs suitable for transplantation in Por-tugal are offered to the Spanish teams, who take care oforgan recovery and subsequent transplantation.

REFERENCE1. Steering committee of the Istanbul Summit. Organ trafficking and trans-


WORKING GROUP 8: EFFECTIVENESS INTHE PURSUIT OF SELF-SUFFICIENCY -

ACHIEVEMENTS AND OPPORTUNITIESLeaders: Luc Noel, Chris Rudge, and Anantharaman

VathsalaMembers: Ines Alvarez, Tamar Ashkenazi, Teodora

Dzhaleva, Gayatri Ghadiok, Sudhir Gupta, Arnt Jakobsen,Martí Manyalich, Rafael Matesanz, Alejandro Nino Murcia,Izaaq Odongo, Ole Øyen, Adib Rizvi, Wojciech Rowinski,Rafael Rozental, Manav Saxena, and Sarah White

A Framework for Progress in the Pursuit ofSelf-Sufficiency

Achieving self-sufficiency is a journey, with the pace ofprogress dictated by resource availability, systems develop-ment, and the extent of national commitment to this goal.Progress may be defined as levels of transplantation capabil-ity, which reflect the evolution and achievements of organdonation and transplantation systems. The objectives of spec-ifying levels of transplantation capabilities are as follows:

a. To ensure that every nation or region has, or acquires,the necessary attitudes, policies and plans, resources,skills, and infrastructure to provide solid organ trans-plantation for its population for the purpose of treatingend-stage organ failure;

b. To provide tools for every nation or region to self-assessits own progress in the pursuit of self-sufficiency insolid organ transplantation for the purpose of treatingend-stage organ failure;

c. To provide tools for nations or regions to identifygaps or barriers to progress in the pursuit of self-sufficiency;

d. To identify the resources required by nations or regionsto resolve gaps or remove barriers that present obstaclesto the attainment of self-sufficiency and to identify pri-ority interventions in the pursuit of this goal;

e. To provide a framework that has relevance in all con-texts, whatever the local reality in terms of economicand health system development, for the stepwise devel-opment of organ donation and transplantation systemstoward self-sufficient models.

Therefore, by defining stepwise levels of transplanta-tion capability, it is possible to construct a roadmap of howindividual nations or regions can progress toward self-sufficiency. Progress from one level of transplantation capa-bility to the next requires government commitment towarddeveloping and implementing policies and programmes,



commensurate with local resources and competing healthpriorities, within each of six key domains:

• Resources and professional development for donationand coordination;

• Legal and regulatory frameworks;• Resources and professional development for transplant

services;• Government and other resources;• Community involvement;• Assessing and minimizing need for organs.

Levels of Transplantation CapabilitySix levels of achievement within each domain are

defined:

Level 1This level defines nations or regions that have a few

medical professionals who have the capability to provideappropriate pre and postsurgical management of transplantrecipients and living donors, taking into consideration guide-lines concerning the care of transplantation patients as devel-oped by international consensus, such as the AmsterdamForum on the Care of the Live Kidney Donor and the Van-couver Forum on Live Donation of Extrarenal Organs. Thislevel also defines nations or regions that have begun to assesstheir needs for renal replacement therapy, including trans-plantation therapy, by developing a registry of end-stage kid-ney disease.

Level 2This level defines nations or regions that have a clin-

ical kidney transplant service within their own borders

with the capacity to provide kidney procurement surgeryfrom living donors, kidney transplantation surgery, andpostsurgical management of kidney transplant patients.The transplant center follows established standards, guide-lines, and care protocols for living kidney donors and kid-ney transplant recipients, taking into consideration therelevant international consensus documents, in particularthe Declaration of Istanbul. The transplant center has de-veloped mechanisms for monitoring outcomes for its kid-ney transplants in key areas including graft and patientsurvival. This level also defines nations or regions that havebegun to assess their needs for organ replacement therapy,including transplantation therapy, by establishing regis-tries of end-stage kidney disease/liver failure/heart failure(as per country needs).

Level 3This level defines nations or regions that have one or

more centers providing clinical kidney transplant serviceswithin their own borders. The transplant centers have es-tablished standards, guidelines, and care protocols for liv-ing kidney donors and kidney transplant recipients, takinginto consideration the consensus documents developed bythe Amsterdam and Vancouver Forums on care of the live do-nor, the Declaration of Istanbul, and the Kidney Disease: Im-proving Global Outcomes (KDIGO) Clinical Practice Guide-lines for the Care of Kidney Transplant Recipients. Thetransplant center has developed mechanisms for monitoringoutcomes for its kidney transplants in key areas including graftand patient survival.

This level also defines nations or regions that areestablishing the framework for a deceased donor kidney

Key Points • In the journey toward self-sufficiency, the capability of individual countries/regions to meet transplantation needs is determined by

economic resources, systems development, and existing health priorities. By defining successive levels of capability, the inclusive nature of the self-sufficiency paradigm is reinforced, and it is possible to describe a framework for evolution and achievement in organ donation and transplantation that is adaptable to all contexts.

• The minimum level of transplantation capability (level 1) is defined as the presence of a few medical professionals who have the capability to provide appropriate presurgical and postsurgical management of transplant recipients and living donors in a context of no local transplantation activity; maximum capability (level 6) is defined as a comprehensive multiorgan transplant programme that provides an adequate supply of transplantable organs to meet the needs of the population.

• At every level, the pursuit of self-sufficiency involves the development and implementation of strategies aimed at increasing regional/national capabilities in each of the following domains: (i) donation and coordination, (ii) legislation and regulation, (iii) transplant services, (iv) government resourcing, (v) community involvement, and (vi) assessment and minimization of needs. With progressive achievements in each of these domains, at a level consistent with local realities, countries/regions evolve toward greater self-sufficiency in organ donation and transplantation.

• To enable the evolution of organ donation and transplantation systems toward models of self-sufficiency, governments should: (i) acknowledge their responsibility and address the problem of end-stage organ failure, from prevention to organ replacement therapy, in an integrated manner for the optimal management of resources; (iii) include the elements of organ donation, and transplantation in the national health plan; (iv) allocate adequate resources, develop infrastructure, and strengthen health systems for the achievement of these goals; and (v) foster regional and international cooperation in the pursuit of these goals.

• To support these efforts, the WHO should: (i) urge all nations to self-assess their level of transplant achievement; (ii) expand data collection and monitor international progress in the pursuit of self-sufficiency; and (iii) develop international standards, guidelines, and tools for the advancement of transplantation policy and practice.

• To support these efforts, healthcare professionals and professional societies should: (i) acknowledge responsibilities with respect to professional development, ethical practices, and maintenance of standards and training in donation, organ procurement and transplantation; (i) encourage research directed at optimizing the benefits and minimizing costs of transplantation; (iii) support the establishment and work of national societies; and (iv) provide professional advice, and assistance in the development of standards for accreditation and quality assurance.



transplant programme within their own borders, includ-ing legislative developments and training of organ pro-curement professionals.

This level furthermore defines nations and regions that,in addition to the development of end-stage organ failureregistries, have begun to address the risk factors for end stageorgan failure by identifying their prevalence in the nation andintroducing interventions to delay its progression.

Level 4This level defines nations or regions that have initiated

deceased donor kidney transplant services within their ownborders and have capacity to perform kidney procurementsurgery from deceased and living donors, kidney transplan-tation surgery, and postsurgical management of kidney trans-plant patients. The nation or region has effected legislationthat covers organ procurement from deceased donors andprovides high level governance over organ procurement andtransplantation activities. The transplant centers have estab-lished standards, guidelines, and care protocols for livingkidney donors and kidney transplant recipients, taking intoconsideration the consensus documents developed by theAmsterdam and Vancouver Forums on care of the live donor,the Declaration of Istanbul, and KDIGO Clinical PracticeGuidelines for the Care of Kidney Transplant Recipients.

This level also defines nations or regions that have aclinical liver and heart transplant service within their ownborders, with the capabilities to provide liver and heart pro-curement surgery from deceased donors, liver and hearttransplantation surgery, and postsurgical management ofliver and heart transplant patients. The transplant center fol-lows established standards, guidelines, and care protocols forliving organ donors and transplant recipients. This level fur-thermore defines nations or regions that are developing otherorgan transplant programmes, including lung, pancreas, andcombined transplant programmes.

Level 5This level defines nations or regions that have an estab-

lished multiorgan deceased donor organ transplant pro-gramme that is capable of providing kidney, liver, and hearttransplantation for its patients with end-stage kidney disease,end-stage liver failure, and end-stage heart failure. Criticalelements of legislation and regulation of the various aspects oforgan donation and transplantation, government commit-ment to resourcing infrastructure and developing profes-sional capacity, governance and oversight by national author-ities, and surveillance and monitoring of organ donation andtransplantation activities are all well established. A national orregional network that optimizes deceased donor organ pro-curement and a framework for organ allocation to patients ona national waiting list is an essential development.

Complementary to the deceased donor transplant pro-gramme, living donor transplantation is performed to pro-vide kidney and liver transplants for a proportion of its end-stage kidney disease and emergent end-stage liver failurepatients, following the standards, guidelines, and care proto-cols set forth in the Amsterdam and Vancouver Forums.

Complementing deceased donor kidney transplanta-tion with LDKT maximizes the rate of kidney transplantation

per million population and the percentage of incident end-stage kidney disease patients receiving a transplant.

Nations and regions with this level of capability haveestablished detailed end-stage organ failure registries for theongoing evaluation of the need for organ transplantation andhave developed and implemented preventive interventions toreduce the demand for organs for transplantation.

Level 6This level defines nations or regions that have a com-

prehensive multiorgan transplant programme that providesan adequate supply of transplantable organs to meet theneeds of its population with end-stage kidney disease, end-stage liver failure, and end-stage heart failure. Other featuresof such a programme include:

• Death of patients on the transplant wait list(s) isnonexistent;

• Travel for transplantation is nonexistent;• The system has capacity to provide expertise to assist the

development of transplant programmes in level 1 to 5nations or regions;

• Exchange of organs between programmes, based on es-tablished guidelines for international cooperation.

RecommendationsGovernments should:

1. Acknowledge their responsibilities in managing theend-stage organ failure of their population, and desig-nate a competent authority, responsible for policymaking, regulation, and oversight and coordinationat a national level;

2. Address the problem of end-stage organ failure, fromprevention to organ replacement therapy, in an inte-grated manner for the optimal management ofresources;

3. Include the elements of organ donation and transplan-tation in the national health plan;

4. Allocate adequate resources, develop infrastructure,and strengthen health systems for the achievement ofthese goals;

5. Establish appropriate legislation and regulatoryframeworks;

6. Report national data on organ donation and transplan-tation activities to a global observatory;

7. Foster regional and international cooperation in thepursuit of these goals;

8. Participate in public education, engaging communities,and NGOs.

The WHO should:

1. Urge all nations to self-assess their level of transplantcapability, to assist in the identification of areas forimprovement;

2. Expand the framework of relevant quantifiable indi-cators in alignment with the GODT (http://www.transplant-observatory.org/);

3. Monitor international progress in levels of achievementin the pursuit of self-sufficiency;




4. Develop international standards, guidelines, andtools for the advancement of transplantation policyand practice.

Healthcare professionals and professional societiesshould:

1. Acknowledge responsibilities with respect to their ownprofessional development, ethical practices, mainte-nance of standards and training in donation, organ pro-curement, and transplantation;

2. Encourage research, especially clinical research directedat optimizing the benefits and minimizing costs of or-gan transplantation;

3. International societies should support the establish-ment and work of the relevant national societies to fur-ther their missions with respect to organ donation andtransplantation;

4. Provide professional advice to MS;5. Provide assistance to MS for the development of stan-

dards for accreditation and quality assurance;6. Participate in public education.

ExamplesThe pursuit of self-sufficiency involves the develop-

ment and implementation of strategic policies and pro-grammes aimed at increasing regional or national levels ofcapability within each of the domains of (1) donation andcoordination, (2) legislation/regulation, (3) transplant ser-vices, (4) government resourcing, (5) community involve-ment, and (6) assessment and minimization of needs. Exam-ples of strategies that have successfully developed capacity forself-sufficiency at a regional or national level are given below:

European Training Programme on Organ Donation(http://etpod.il3.ub.edu/etpod.html)

The European Training Programme on Organ Dona-tion (ETPOD) project was conceived with the objectives of:(1) developing and validating a professional ETPOD thatwould increase organ donation knowledge and maximizegrowth of organ donation rates; (2) providing training tohealthcare professionals from EU countries, to developTransplant Coordinators with the expertise, competencies,and motivation in the organ donation process to lead efficientand successful organ donation-procurement programmes;and (3) to build a solid European collaborative partnershipin the organ donation-transplantation process that will en-able countries to respond to the growing demand for trans-plantation by increasing donation rates. Cofunded by theEuropean Commission Grant Agreement 2005205, theproject was developed during the period from January2007 to December 2009. The execution of the project wascarried out through four working groups:

• Data Base Source Group—responsible for establishingthe training needs in each target area and for evaluationof the ETPOD project;

• Basic Training Group—responsible for training fortrainers and essentials in organ donation (EOD) trainingprogrammes;

• Professional Training Group—responsible for profes-sional training on organ donation and e-learning virtualmodules;

• Managers Training Group—responsible for managerstraining on organ donation.

One hundred twenty-five health professionals weretrained by the ETPOD project in each of 25 target areas acrossEurope, with this number including 2 senior transplant coor-dinators (training for trainers), 2 junior transplant coordina-tors (professional training), 1 transplant area manager (organdonation quality managers training), and 120 health profes-sionals involved in donor detection (EOD).

ETPOD in Turkey (communication from LeventYucetin): eight EOD seminars were held in Ankara be-tween September and October 2009, with 500 participants. InDecember 2009, eight EOD seminars were held for 1600 par-ticipants in Istanbul. Another four EOD seminars were heldin April/May 2010 for 700 participants in Izmir.

Evaluation of the impact of ETPOD on organ donationrates at national, regional, and local level (communicationfrom Gloria Paez): to evaluate the effect of ETPOD courses,data on key indicators were collected in 2006 (before projectcommencement) and again in 2009. The impact of the train-ing programmes on rates of brain death diagnosis, identifica-tion of potential donors, refusals, effective donors, and pro-cured organs was assessed for each of the target areas. Thenumber of procured organs increased in 19 of the 25 targetareas, from 1242 in 2006 to 1483 in 2009 (1). Assessed permillion population, procured organs increased from 43.2 to51.8 per million population, whereas brain death diagnosesincreased from 28.2 to 39.8 per million population. The im-portance of donor coordinators was emphasized in this eval-uation—those target areas which had increased their numberof coordinators between the years 2006 and 2009 demon-strated significantly greater improvements in organ procure-ment than those target areas with a steady or reduced numberof personnel devoted to coordination in 2009 compared with2006.

Gift of Life Donor Programme (UnitedStates—Communication From Howard Nathan)

Gift of Life (Philadelphia, PA) is an urban-based, non-profit OPO/Tissue Recovery/Eye Bank established in 1974that is the largest in the United States with approximately 34staff in the field, divided between procurement and educa-tion/marketing professionals, and generating the highest vol-ume of organ donors in 2009 in US history (439 organ donorsfrom a population of 10.2 million).

The Pennsylvania Act 102 was initiated by familieswhose loved ones died waiting for a transplant. Originallydrafted as a presumed consent law, the provisions of the Actare as follows:

• Routine referral of all deaths to the OPO at or near thetime of death;

• Medical suitability of potential donors determined byOPO personnel;

• Family approached by trained requestor/OPO person-nel with hospital staff;


http://etpod.il3.ub.edu/etpod.html


• Medical record reviews to determine donor potentialand missed referrals of all deaths, with provision for finesfor missed referrals.

Therefore under PA Act 102, routine referral started in1994. The law states that hospitals are required to refer all patientdeaths and imminent brain deaths to the OPO in a timely man-ner, so that medical suitability can be evaluated and that theoption of organ donation is preserved for families. The standardeducational message to the hospital staff was to refer all nonre-coverable, neurologically injured, vent-dependent patients at thefirst sign of imminent brain death. Clinical parameters for refer-ral were not specified, removing barriers to early reporting andencouraging hospital staff to call the OPO as soon as this type ofpatient presented in the emergency room (ER) or ICU. A topdown approach to hospital development was adopted, reinforc-ing the early referral message to administrators, physicians, andnurse managers on a one-on-one basis. Maintaining the com-mitment to send a coordinator out on site for every referral thatfit criteria is critical to the routine referral policy.

Because of the success of PA Act 102 in the Gift of Lifeservice area, from August 1998, a National Routine Referralpolicy was introduced whereby all US hospitals were requiredby Medicare to adopt routine referral as a “condition of par-ticipation.” Over the 15 years since the introduction of the PAAct 102 for Routine Referral, Gift of Life has experienced adoubling in rates of organ donation. These positive outcomesextend beyond organ donation; bone donation has increasedin the Gift of Life jurisdiction from 174 donations in 1992,before the introduction of Routine Referral, to 1026 dona-tions in 2009.

SEUSA (Spain, Europe, United States—CommunicationFrom M. Paula Gomez)

In response to low organ donation rates in Apulia, aSouth-Eastern Italian region, a new international collab-orative strategy to increase donation activity was intro-duced in 2007. This collaboration involves internationalexperts from Spain, Europe and the United States workingwith the Apulia Transplantation Regional Center (ATRC),Azienda Ospedaliero—Universitaria Policlinico di Bari,with the goal of reorganizing the entire regional organ do-

nation system. This SEUSA programme includes: (1) insti-tution of area coordinators, (2) periodic meetings withICU coordinators and hospitals leaders, (3) implementa-tion of technical strategies to better detect all brain andheart deaths in ICUs, (4) constitution of an organ and tissuesprocurement team in each ICU, (5) allocation of dedicated fi-nancial resources direct to the procurement system, and (6)training courses for members of the procurement teams. Anal-ysis of data on procurement parameters in 21 ICUs from theATRC computer network, registered before and after the com-mencement of the programme, indicated a significant increaseduring the first 2 years of the Spain Europe USA (SEUSA) pro-gramme in of the number of brain death assessments and organdonors and a decrease in the refusal rate.

However, despite the successes of the first 2 years ofthe programme, organ donation rates in the Apulia regionremained lower than the Italian national average rate, withindications that potential donors were still not being effec-tively identified. Therefore, in January 2009, Apulia intro-duced a Deceased Alert System (DAS), a new monitoringand reporting system for brain and circulatory death,which functions synergistically with the Registry of HeadInjury and the Donor Manager. Under the DAS, when anICU patient has a severe acute brain injury or goes intocirculatory death, an automated message is sent throughthe internet to the ATRC and simultaneously to the mobilephone of the local coordinator, who is therefore kept up-to-date in real time one the presence of a potential donorin the ICU and can therefore initiate appropriate proce-dures. During the first 5 months of the DAS being opera-tional, actual donors increased by more than 57%. Referralof potential donors increased gradually with increasingconfidence in the new system, and these initial data indi-cate that increasing use of the DAS could significantly re-duce losses of potential donors through failure to report.

REFERENCE1. Ferraro C, Vespasiano F, Ricci A, Caprio M, Di Ciaccio P, Nanni Costa

A, Guash X, del Rio M. Impact of ETPOD on organ donation rates atNational, Regional and Local level. Comparative report on organ do-nation rates before and after training implementation. EuropeanTraining Programme on Organ Donation [ETPOD], February 2009.


APPENDIX 1: Expanded Report on SystemRequirements for the Pursuit of Self-

Sufficiency (Working Group 2)To achieve self-sufficiency, it is necessary to both min-

imize the need for transplantation and maximize the utility ofavailable resources through efficient organ procurement,successful transplantation, and optimal graft survival. Thisrequires a number of specific system-related, structural, or-ganizational, and regulatory developments.

ESSENTIAL LEGISLATION ANDREGULATION

LegislationLegislation is necessary to ensure that clear definitions

of brain death and circulatory death exist to allow procure-ment of organs from deceased donors. It is also required todefine protocols concerning consent, including presumedconsent, and the fair and transparent allocation of organs.Finally, legislation must govern transplantation practice inaccordance with the WHO Guiding Principles. In particular,this means promoting the altruistic character of organ dona-tion and prohibiting organ trafficking and commercialism.

a. Legislation concerning organ trafficking: consistentwith the WHO Guiding Principles, each country re-quires legislation prohibiting organ trafficking and salesto prevent human rights abuses. The export and importof organs or tissues or cells and transplantation for for-eign patients should also be governed by legislation.

b. Legislation concerning declaration of death: each coun-try performing deceased donor transplantation must le-gally define brain death, consistent with internationalstandards. There should be legal provision to removeorgans from a deceased person, in accordance with localstatutes on determination of brain death and circula-tory death.

c. Legislation concerning organ procurement procedures:organ recovery can only be justified through a strictconsent process that is guaranteed by autonomy ofthe donor who is sufficiently informed or in the settingof legislated presumed consent to donation after death(1). Organ donation from living persons who are mi-nors or individuals unable to provide informed consentshould be prohibited (2). Although it is hoped that theconsent of relatives to donation after death will be ac-tively sought in all circumstances, in some jurisdictionswhere the preferences of relatives may conflict withthose expressed by the potential deceased donor, thelatter may be upheld (This is not the case in all countries.In practice, relatives’ wishes are often upheld over do-nor wishes. See Uniform Anatomical Gift Act, UnitedStates).

d. Legislation to establish transparent organizationalstructures and authorities for the coordination of organdonation and transplantation (refer Monitoring andRegulation of Organ Donation and Transplantation, Or-gan Procurement Organizations, National Donation Pro-motion Programmes, Hospital Transplant Programmes).

e. Legislation guaranteeing transparency of organ alloca-tion: the criteria for organ allocation should be set inaccordance with medical utility, mindful of the charac-teristics, and preferences of each region or country andthe principle of equity (3).

f. Presumed consent for donation after death (optional):legislation may be enacted to establish presumed con-sent for organ donation. This may be effective in in-creasing potential deceased donors, provided there issocial consensus regarding presumed consent (4, 5).For example, in Spain and France if a brain-dead per-son has never expressed his or her intention for do-nation, his or her consent is legally presumed (6). InGermany and selected other European countries,from 13 years of age, individuals may draw up a doc-ument rejecting donation of their organs, and there-fore, persons with such a document are considered tobe objectors to organ donation, and persons withoutsuch a document, assenters. The presumed approachhas contributed to an increased provision of organsfor these countries, but the local sociocultural con-texts of different counties need to be considered be-fore enacting a mandatory system.

g. Routine Inquiry laws: for example, Required RequestLegislation introduced in the United States in 1986 re-quires that hospitals or their designees ask families ofpatients and potential donors about their wishes con-cerning organ donation (7).

RegulationRegulatory bodies should monitor the activities of

organ procurement, allocation, and transplantation organi-zations to ensure they take place in accordance with local,regional, and international law and in an ethical and effectivemanner. Regulation is necessary for oversight and guidancerelated to ethical standards, the development of transplanta-tion policies, and quality management in all organ procure-ment and transplantation practices.

a. Transplantation ethics

• Regulatory bodies have an important role in establish-ing ethically appropriate organ procurement and allo-cation processes.

• Ethics committees, under the local, regional, or na-tional regulatory authority, guide (1) organ procure-ment processes such as informed consent, (2) theimplementation of new procedures or practices thathave ethical implications, such as DCD, and (3) eligibil-ity criteria for living donors and approving the relation-ship between a potential donor and a recipient.

b. Development of transplantation policy

• Through surveillance and data collection, regulatorybodies are able to review existing processes and developmore effective transplantation policies. Data relevant totransplantation policies include the reported rate ofbrain deaths in each hospital, factors contributing tononprocurement from potential donors, and donorand recipient outcomes. For example, in the UnitedStatesm a death audit is carried out every year andidentifies, according to the medical records, whether



potential donors have been missed. All hospitalsshould have a continuous quality audit programmeconcerning brain deaths to ensure that every braindeath patient has been detected and evaluated by thetransplant coordinator.

• Regulatory bodies must evaluate and make recommen-dations concerning the appropriate standards for age,disease, use of ECDs, and DCD.

• Regulatory bodies must additionally consider, andimplement where appropriate, innovative strategiesfor increasing the availability of donor organs such aspaired kidney exchange programmes between livingdonors (8).

• Regulatory bodies are also responsible for the develop-ment of whole-of-system strategic policies to bettermeet the transplantation needs of the population. Ex-amples of comprehensive strategic policy include:

– The Organ Donation Breakthrough Collaborative(United States): started in 2003 to vitalize organ DBDand also promote best practice in organ donation, theBreakthrough Collaborative targets hospitals orOPOs with a large potential in terms of DBD. Eachhospital is encouraged to identify opportunities forimproving practice and collaborate with OPOs in theintroduction of new strategies to enhance organ pro-curement. After implementing this system, DBD in-creased by 4% (9–11);

– The “40 donors per million population plan” (Spain):Spain is trying to increase its rate of organ donationfrom deceased persons to 40 donors per million pop-ulation, by targeting the key areas of (1) detection andmanagement of brain-dead donors, with specific fo-cus on access to ICUs, new forms of hospital manage-ment, foreigners and minorities, and evaluation/maintenance of thoracic organ donors; (2) ECDs,looking at aging, donors with positive tests to certainviral serologies, and donors with rare diseases; (3)special surgical techniques, and (4) DCD. In addi-tion, Spain seeks to open new DCD programmes incities with more than 300,000 inhabitants and try-ing to reduce the rate of potential donor families’refusal to 10% (12).

c. Transplantation quality management and professionaleducation

• Regulatory oversight helps to standardize, and maintainquality in, transplantation performance by promotinguniform procedures and monitoring the performance ofeach individual transplantation center.

• Regulatory bodies are responsible for ensuring ade-quate education and training of transplant staff, for ex-ample:– United States: transplant professionals must demon-

strate the ability to execute their tasks independentlyand pass a test hosted by North America Transplant

Coordinator Organization, which also provides con-tinuing education, conducts research, and gives ad-vice concerning organ procurement processes (13);

– Spain: the Transplant Procurement Management(TPM) curriculum includes family meetings and con-sent of organ donation.

THE NATIONAL TRANSPLANTORGANIZATION

National Transplantation Organizations (NTO) em-body all processes involved in organ procurement and trans-plantation at the governmental level. Although they may beresponsible for various functions such as the management ofwaiting lists, matching and allocation, and the maintenanceof comprehensive registries, above all they should ensurethe implementation of national policy concerning dona-tion and transplantation. Hence, the NTO must have regula-tory functions and provide effective oversight of all activitiesin organ donation and transplantation, monitor trends andperformance, and guide informed policy.

Allocation of OrgansThere are two models of organ allocation: a centralized

system led by government (e.g., ONT, Korean Network ofOrgan Sharing [KONOS]) or private corporation aggregaterun by a non-profit corporation (e.g., UNOS). Regardless ofthe structure of organ allocation bodies, their operation andorganization should be intimately connected with the NTO.Examples of organ allocation models:

a. The EIF, found in 1967, is responsible for the mediationand allocation of organ donation procedures in Austria,Belgium, Croatia, Germany, Luxemburg, the Nether-lands, and Slovenia (http://www.eurotransplant.org).

b. Agence de la Biomedicine (France) is the public body inEurope to combine the four allocation region services derégulation et d’appui (SRA) of organ procurement (http://www.agence-biomedecine.fr/).

c. KONOS: a government controlled system responsiblefor registry, allocation, and database management forthree geographic regions (http://www.konos.go.kr/).

d. ONT, Spain: a system of interdependence between dis-tinct/regional based procurement arrangements, whichworks as part of a NTO (http://www.ont.es).

e. UNOS (United States): the national UNOS membership isdivided into 11 geographic regions for procurement, allo-cation, and transplantation (http://www.unos.org).

To maximize utility, organs are generally allocated basedon medical urgency and blood/tissue type matches. Distributionis usually made first on a local, then regional, and finally nationallevel. Kidney and pancreas allocation is usually made based on apoint system, using an algorithm that takes into account bloodgroup, waiting time, type of HLA match, degree of sensitization,and age. Local patients with the highest points are allocated the

Suggestions for enhancing progress toward self-sufficiency through legislation and regulation: ► Proper legislation and regulation ► Policy making for improved organ donation ► May adopt “presumed consent” or “explicit consent” by legislation or regulation


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http://www.agence-biomedecine.fr/

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organs in descending order, then they are distributed regionallyin descending point order, and finally nationally, in the same order(14, 15). Liver allocation takes into account degree of medical ur-gency, blood group, and time waiting and also used a point-basedsystem for these factors. Degree of urgency is classified using a scor-ing system such as Mayo End-stage Liver Disease score (16–18).

Monitoring and Regulation of Organ Donationand Transplantation

Registries play a vital role in transplantation systems,including maintenance of the organ transplant waiting listand facilitating the allocation of organs from deceased donorsin accordance with transparent distribution criteria (seeWorking Group 4). They also enable review of the currentstatus of donation and transplantation, thereby facilitatingquality control, evidence-based research, and the develop-ment of policies that are guided by the best available informa-tion concerning the management of patients and their needs.Each country performing transplantation should develop aregistry of organ donation and transplantation activities.

Transplantation authorities need access to transplanta-tion data for several policy and regulatory purposes. Key ap-plications of registry data include:

a. Performance standards: transplant data can be used toassess and set performance standards for transplantcenters. The data can be used to evaluate the number oftransplants performed by individual transplant centersand the outcomes at those centers. The data can showthe impact of patient mix on patient and graft survivaland the effects of race, blood type, and other variableson pretransplant waiting time.

b. Legislative and regulatory policy: transplant data areimportant for setting government policies and passinglaws related to transplantation. For example, data canbe used to determine the impact of federal OPO regu-lations that require demonstrated ability of each OPOto meet a minimum procurement rate. Data can also beused to determine the effects of cold ischemia time(time without blood supply to the organ) on graft sur-vival. Such information can be used to develop optimalgeographic organ sharing policies.

c. Quality control: data can also be used to examine suchissues as accuracy in histocompatibility testing and graftsurvival for specific transplant procedures.

d. Internal benchmarking: registry data are also useful forhealthcare professionals and research organizations forimproving practices and setting standards. It also helpsto facilitate communication with relevant internationalorganizations concerned with transplantation.

Best practice with respect to registries consists of,where possible, computer-based, real-time sharing of do-nor information. For example, when donor information is

provided to the EIF and UNOS (DonorNet®) computersystems, staff at the hospital where the transplant candi-date is located can share real-time information and showintention of acceptance in the system, by which allocationand distribution are made. Other examples of registriesand large-scale databases in organ donation and transplan-tation include:

a. SRTR (United States): supports the ongoing evalua-tion of the scientific and clinical status of solid organtransplantation. The SRTR contains current and pastinformation about the full continuum of transplantactivity, from organ donation and waiting-list candi-dates to transplant recipients and survival statistics.This information is used to help develop evidence-based policy, to support analysis of transplant pro-grammes and OPOs, and to encourage researches onissues of importance to the transplant community(www.ustransplant.org).

b. Collaborative Transplant Study (Europe): with the ac-tive support of more than 400 transplant centers in 45countries, the Collaborative Transplant Study is thelargest international voluntary study in the field ofmedicine. More than 400,000 datasets for kidney, heart,lung, liver, and pancreas transplants have been col-lected. This wealth of data has provided invaluableinsights into transplantation-related problems suchas effects of immunosuppressive drugs, long-termtoxicity of immunosuppressant, causes of long-termgraft loss, factors influencing patient survival, etc(www.ctstransplant.org).

c. Sistema Nacional de Informacíon de Procuracíon yTrasplante (Argentina): run by the National Institutefor Organ Donation and Transplantation Instituto Na-cional Central Unico Coordinador de Ablación e Im-plante (INCUCAI), Sistema Nacional de Informacíonde Procuracíon y Trasplante is an online data systemthat administrates, manages, and supervises organ, tis-sue, and cell procurement and transplantation activitiesin the national field. It allows online monitoring of di-alysis registries, waiting lists, procurement procedures,and the distribution and allocation of organs and tis-sues. It also facilitates traceability from donor to recip-ient and vice versa. The data are used to generate reportsabout transplant activity from organ donation and wait-ing-lists patients, to transplant recipients (http://www.incucai.gov.ar).

ORGAN PROCUREMENT ORGANIZATIONSAn OPO is an independent organization responsible

for the process of systematic surveillance for the identifica-tion of potential donors and the procurement of deceaseddonor organs (19). The identification of potential donors is

To enhance progress towards self sufficiency, NTOs should: Be the main authority for organ transplantation programmes Maintain transparency in organ allocation Maintain a useful national data system Promote innovation to increase the donor pool, including consideration of paired kidney exchange programmes between living donors Develop allocation policies for expanded criteria donors and donation after circulatory death


www.ustransplant.org

www.ctstransplant.org

http://www.incucai.gov.ar

http://www.incucai.gov.ar


the starting point of transplantation, and its optimization ispossibly the most important process in maximizing the pro-curement of organs for transplantation.

Structure of an OPOIn setting up an OPO, its region of jurisdiction/respon-

sibility will be influenced by population size, geographicalfeatures, and the number and size of hospitals and transplan-tation centers available. Limits must be set to ensure theregion is appropriate for management by a central OPO re-sponsible for the distribution of organs for transplantation.OPOs require the involvement of experts concerned withmedical administration, clinical management, logistics,education and so forth, and the support of a variety ofinstitutions.

OPOs are divided into two organizational models:HOPOs and IOPOs. HOPOs originally served as exclusiveprocurement entities for the transplantation facilities inwhich they were located. IOPOs operate outside the hos-pital setting and provide services to a number of transplantcenters. IOPOs are usually structured as non-government,nonprofit organizations. Regardless of the model, thereshould be an approval process involved and oversight pro-vided by appropriate government authorities to ensuretransparent management. In both models, procurementactivity occurs independently from transplant units, al-though transplant surgeons are in charge of organ recov-ery. Decisions about the adoption of a particular system oforgan procurement should be made with consideration ofeach national and regional situation. The following sec-tions review the advantages and disadvantages of bothmodels.

a. HOPO• Advantages: because a HOPO creates no additional

costs, it would be suitable for a country with onlyone transplantation center or just starting deceasedtransplantation.

• Disadvantages: HOPOs are often hampered by fund-ing conflicts and inefficiencies. In addition, the identi-fication of potential donors is likely to be unsystematicbecause of the small scale of operations of an HOPOcompared with an IOPO. Furthermore, HOPOs arevulnerable to ethical conflicts because of the in-housenature of their operations.

b. IOPO• Advantages: IOPOs are more effective in organ pro-

curement than HOPOs, because they have a larger in-tegrated system and a centralized authority, that canhelp to provide more consistency of service, minimizeinefficiencies, and optimize the potential donor poolthrough large scale programmes of education and sur-veillance. In the United States, an organ procurementsystem has evolved gradually from an HOPO- to anIOPO-based system.

• Disadvantages: this system may be financially unviableor practically inappropriate in countries lacking mul-tiple transplantation centers.

• Examples:– Instituto Nacional Central Unico Coordinador de

Ablacion e Implante (INCUCAI, Argentina) is

responsible for donor detection, screening andmanagement, organ distribution, and allocationcoordinating 24 OPOs around the country(www.incucai.gov.ar);

– Agence de la Biomédecine (France) is a public bodycombining the four allocated regions (SRA) for or-gan procurement (www.agence-biomedecine.fr);

– Deutche Stiftung Organtransplantation (Germany):since 1984, Deutche Stiftung Organtransplanta-tion has conducted identification of potentialbrain death donors and organ extractions; how-ever, allocation is executed by Eurotransplant(www.dso.de);

– Korea Organ Donation Agency (KODA): set up in2009, KODA is responsible for donor detection,screening, and management in each three geo-graphic regions, working separately from KONOS(www.koda1458.kr);

– ONT, Spain: ONT is in charge of the national net-work of OPOs (www.ont.es);

– UNOS (United States): under UNOS are 59 OPOs in11 regions, working with transplant medical institu-tions, laboratories, and civic groups (www.unos.org).

Personnel Involved in OPOs

a. OPC: OPOs may employ highly trained professionalscalled procurement coordinators who carry out the or-ganization’s mission (20). The OPC is a key person re-sponsible for integrating the actions noted above; forpossible donor detection, donor management, workingwith donor families, hospital staff, and also develop-ment of donor detection programmes and protocoletc. Therefore, OPC need to maintain professionalqualification by regular education and certificationeligibility (American Board for Transplant Certifica-tion, www.abtc.net, USA; Transplant ProcurementManagement, www.tpm.org, Spain).

b. Physicians and nurses: nephrologists, critical care spe-cialists, and also other physicians and nurses can engagein the activities of the OPC. An OPC needs to be able tomanage both ECDs and DCD.

c. Subordinate coordinators: in the case of LifeLink (At-lanta, United States), the roles of the OPC are dividedacross a local call center, referral coordinator, desig-nated coordinator, surgical coordinator, and organplacement coordinator; each department is responsiblefor specific tasks. Some OPOs may also employ “after-care coordinators.”

d. Organ donation representative or organ facilitator: thisperson may help to identify potential donors within afacility. In countries with a limited number of OPCs,designated experts within a hospital may take on therole of organ donation representative.

e. Team or committee responsible for brain death diagno-sis: may include two or three medical specialists includ-ing a neurologist.

f. Organ procurement team: transplant surgeons,physicians, and medical staff of the OPO work in col-laboration with each other. A standardized donormanagement protocol, or a Critical Pathway, for or-gan donation after death is an important tool to en-


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able the work of the organ procurement team and theeffective identification of all possible deceased donors(see also Working Group 3).

The Functions of the OPO

a. Surveillance: the detection of potential donors needs tooccur at every acute hospital. For example, the DonorAction Programme (www.donoraction.org), originat-ing in Europe, is a quality management programme de-signed to maximize the donation potential of hospi-tals by conducting a diagnostic review of practices,including a medical record review and hospital atti-tude survey, enabling hospitals to identify problemsand find solutions (21).

b. Donor management: the recovery of viable organs fortransplantation is dependent on appropriate medicalmanagement both before and after brain death. Themedical team managing the potential donor must an-ticipate and prevent or detect and treat abnormalitiesthat can cause circulatory collapse or permanent dam-age to otherwise transplantable organs, which ulti-mately make it possible to recover better functioningand multiple organs without loss (22, 23).

c. Procurement: potential donors should be carefully as-sessed to exclude contraindications to donation pend-ing the necessary clinical and legal procedures requiredto establish and certify brain death (24). The relativeswill have to be approached and interviewed to obtainformal consent or to obtain a social history about thepotential donor. Adequate support for the family fromtrained staff (preferably a procurement coordinator) atthis time is essential; once consent for donation is fi-nalized, the procurement coordinator manages theclinical care of the donor together with the hospitaldonor management team. Donor information is pro-vided to the donor allocation center to find a matchfor the donated organs. The procurement coordina-tor also coordinates the organ recovery process withthe surgical teams and provides follow-up informa-tion to the donor family.

Suggestions for Enhancing Progress TowardSelf-Sufficiency Through OPOs (Fig. 8)

a. Optimize identification of potential deceased donors,through:• Instituting quality management programmes, as in the

example of Donor Action (www.donoraction.org);• Facilitation of the interaction between the OPC and

transplantation team in local hospitals;• Assisting hospitals to develop systems for flagging po-

tential deceased donors;• Provision of education for medical staff throughout the

hospital, in particular in emergency and ICUs;• Conducting death audits, healthcare financing adminis-

tration, condition of participations, compliance moni-toring, etc;

• Providing official recognition and support to hospitalsto achieve high rate of organ donation;

• Use of mandatory reporting for candidate deceased donors.

b. Best practice management of potential deceased donors,through:• Standardization, development, and implementation of

critical pathways for donor management;• A team approach to donor management, including a

member of an OPO;• Real-time reporting of the donor’s condition to trans-

plantation teams preparing for surgery (25).

c. Optimize organ procurement, through:• Standardization and development of critical pathways

for organ procurement;• Establishing coordination teams for organ procurement

in hospitals;• Use of state-of-the-art systems to find the fastest and

most cost-effective ways of sending and organ fromone city to another (e.g., Multi-Agent System) (26);

d. Support for the expenses for organ removal and trans-plantation, through:

• Governmental support for management of potential do-nors and expenses incurred in procurement, and sup-port for necessary hospital infrastructure. Whatever thesystem, it is essential that socioeconomically disad-vantaged persons should not be denied the opportu-nity to donate or the ability to access transplantation.

e. Improved management for the bereaved, through:

• Aftercareprogrammesforrelativesofdonors(especially intheearly period, using a letter of thanks, reporting of organ shar-ing, etc., may provide great comfort to the bereaved);

• Commemorative works such as a memorial park, whichcan encourage positive recognition among relatives ofdonors and the public.

f. Increase organ procurement from marginal donors,through:

• Maximal use of ECD and DCD donors;• Utilization of deceased donor organs from potential co-

ronial cases (Unexpected deaths with no obvious causeof death require mandatory reporting to coroners insome countries and often require autopsies. However,organs could be removed by an organ procurementteam after reporting to a medical examiner/coroner’s

FIGURE 8. Key strategies for adoption by Organ Pro-curement Organizations (OPOs) to enhance progress to-wards self-sufficiency.


www.donoraction.org

www.donoraction.org


office, and the report during the process could be ap-proved as an autopsy report).

NATIONAL DONATION PROMOTIONPROGRAMS

Organ procurement is not just a matter for health au-thorities, OPOs, and specific hospital personnel. The entiremedical community and society as a whole need to be awareof this challenge and become involved, indirectly or directly,in the process of organ procurement (see Working Group 6).

Organization of Donation PromotionPublic awareness of organ donation should be lead by

the government and its agencies, in collaboration with rele-vant NGOs. The resulting coalition of different entitiesshould be coordinated at a national level to ensure consis-tency of messages and reliability of information, althoughindividual organizations should also strive to maintain spon-taneity and creativity in their strategic approaches. NGOscontributing to donation awareness may have different focusof interest, yet synergies between them should be encouraged.

Examples of donation promotion programmes func-tioning at a national level include: Donate Life America, anNGO founded in 1992 to educate the public about organ,eye, and tissue donation; the Korean Donate Life Network(KodoNet), also an NGO, and; Donate Life Australia (Seewww.donatelife.org.au), a programme funded by the Fed-eral Australian Government.

The Role and Potential Activities of NationalDonation Promotion Programmes

a. Publicity: for example, conduct a nationwide organ do-nation campaign regularly, use specification of intent todonate on driver licenses, introduce donor cards,awareness campaigns, or tokens such as an organ dona-tion ribbon, donor memorial events such as a “nationalDonor Day,” construction of monument or memorialpark, etc.

b. Information: target all media for regular release of pub-lic information, using printouts, broadcasting, radio,and Internet.

c. Research: seek feedback from living donors and thefamilies of deceased donors.

d. Acknowledgment: support the family of deceased do-nors, recognize their involvement and share stories andexperiences.

e. Education: consistency of educational content is essen-tial, as is the evaluation of the efficacy and quality ofeducation programmes. There is a need to dispel mythsand misconceptions about donation after death and totarget the content and delivery of education pro-grammes to the specific characteristics of their intendedaudience (27). Education should be delivered at the levelof schools, the general public, and medical profession-als. Education concerning the importance of organ do-nation after death should be delivered iteratively as partof health curricular, from elementary to high school,and include education on brain death. Professional ed-ucation is especially important for hospital staff work-ing in regional areas, where donation occurs in collab-

oration with a variety of medical teams and individualsmay play multiple roles in the absence of extended sup-port from OPOs. Education efforts should be supportedby promotion of registration of intent to donate afterdeath.

f. Relationships with the media: establishing good rela-tions with the media will facilitate the timely release ofappropriate information and news into the public do-main. Regular meetings with the media will establishrelationships that are crucial in the setting of crises andevents that may be negatively influenced in the absenceof clear messages.

g. Hotline: a telephone hotline may be helpful in provid-ing information directly to members of the public andto medical professionals.

HOSPITAL TRANSPLANT PROGRAMSTo contribute to progress toward self-sufficiency, hos-

pital transplantation programmes should strive to achieve thefollowing goals:

• Enhancement of graft survival,• Increased procurement of organs and enhanced utility

of transplanted organs,• Promotion of medical excellence in transplantation and

donation care,• Promotion of ethical practice in transplantation and

donation,• Promotion of education and training of transplant

professionals.

Components of Hospital TransplantationProgrammes (Fig. 9)

a. Personnel• Medical staff: specialist physicians involved in trans-

plantation include transplant surgeons, transplantationphysicians, and anesthesiology staff, who are essentialfor successful operation and management of transplan-tation patients.

• Transplantation coordinators: responsible for ensuringthat all elements of evaluation and postoperative pro-cesses are in place (28, 29). Transplant Coordinators(TCs) also perform the review and updating of hospitalprotocols, quality assessment, quality assurance, datacollection, and research. The specific duties of the rolevary for each individual center.

b. Facilities• Intensive and high dependency care unit: these are

essential, especially for patients who undergo majorheart and lung transplants, and also for deceased do-nor management.

• Hemodialysis unit: should be available for patients whoexperience delayed renal graft function or other condi-tions with decreased renal function.

• Transplantation laboratory: these perform investiga-tions to determine donor and recipient compatibilityfor transplantation, including tissue typing between adonor and a recipient and serum screening panel reactiveantibody (PRA)/crossmatching, and also monitor


www.donatelife.org.au

related infections including cytomegalovirus, Ep-stein-Barr virus, BKV, and immunosuppressive drugconcentration. In addition, pathology laboratory sup-ports the assessment of graft viability/rejection.

c. Organ procurement: hospitals have a variable capacity toperform organ procurement. Some may have procure-ment facilities and staff available, whereas others may beable to identify and maintain potential donors but notperform all (or any) types of procurement. For example:

• Germany: hospitals are divided into three categories.Category A: University Hospital; category B: hospitalthat has a neurosurgery unit; category C: hospital thatdoes not have a neurosurgery unit.

• France: donor hospitals are assigned into three typesby Agency de la Biomedicine, the body providingnational oversight of organ procurement. Type 1:hospital for donor detection; type 2: hospital for or-gan procurement; and type 3: hospital for both organprocurement and transplantation.

Hospitals will require different facilities (e.g., laborato-ries, electroencephalogram machines, sample banks) accord-ing to the category into which they fall.

Management of the Hospital TransplantProgramme

For effective management of the various interrelatedcomponents and potential challenges of providing transplan-tation services and procuring organs, it is necessary to have amanagement team within transplanting hospitals that is re-sponsible for oversight of the activities of the transplantationprogramme. This team should work independently from thetransplantation and procurement teams to ensure transparencyand efficacy of regulation and oversight. The Director of theTransplantation Center should work closely with other groupsin and outside of the hospital. Management of transplantationprogrammes at the hospital level needs to incorporate:

a. An ethics committee (Ethics Committee: AmericanSociety of Transplant Surgeons; available at: www.asts.org): the hospital ethics committee will considervarious ethical issues such as the eligibility of living do-nors, provide oversight of organ allocation, and alsoguide the implementation of new procedures or prac-tices that have ethical implications, such as DCD.

b. A death determination team (30): a death determinationteam (responsible for determining and declaring brainand circulatory death) should be established to ensure thatthe independent determination of death of all potentialdonors occurs in a transparent and ethical manner consis-tent with local brain death legislation.

c. Education and quality control: a team should help toensure the ongoing education of medical and nursingprofessionals involved in the transplant programme,monitoring the quality and effectiveness of educationalactivities to ensure maintenance of the highest possiblestandards.

d. A public relations team should also assist in educationinitiatives aimed at the general public and coordinatethe release of information about local transplant activ-ities to the media.

Strategies for Adoption by Hospital TransplantProgrammes to Enhance Progress TowardSelf-Sufficiency

To achieve self-sufficiency, it is important to expandthe donor pool and to improve the outcomes for patients.Therefore, it is recommended that hospitals consider imple-menting the following strategies:

a. The ECD: a major concern regarding ECD kidneys ispoor long-term graft survival. However, recent studieshave showed 5-year graft survival to be comparable withstandard grafts, although ECD grafts had slightly worsefunction. Therefore, utilization of ECD is likely to havea role in achieving self-sufficiency. In the United States,a modified allocation policy for deceased donor kidneyswas put into place in 2002, whereby transplant candi-dates are now asked to indicate whether they are willingto consider ECD kidneys at the time of placement on thewaiting list. ECD kidneys are allocated from this sepa-rate supplementary list by waiting time, without consid-eration of HLA matching, to a preinformed group ofcandidates (31). In Spain, policy related to the active useof organs from aged donors was established in 1990,resulting in donors aged 60� years now accounting for46.6% of all donors.

b. DCD: there is still a general reluctance to use DCD forkidney donation and transplantation, because of a rela-tively high incidence of delayed graft function and pri-

FIGURE 9. Essential components of hospital transplant programmes.


www.asts.org

www.asts.org


mary nonfunction compared with conventional DBD.However, optimal organ preservation and careful selec-tion of kidneys from DCD may reduce these risks ofdelayed graft function and primary non-function (32).

COORDINATION SYSTEMSMultiple systems functioning at the local, regional, and

national level are involved in the processes of organ dona-tion and transplantation, and the effective coordination ofthese various systems is fundamental to the pursuit of self-sufficiency. Each country needs to have a national organ do-nation and transplantation coordination system that fits withits particular organizational structures and components. Co-ordination may also extend beyond national borders.

Levels of Coordination in Organ Procurement(Fig. 10)

The institutions involved in the process of organ pro-curement may operate at three different levels of coordina-tion (national, regional, and local), each of which should besystematically integrated.

a. Local (hospital level): at this level, the coordination oforgan procurement involves a physician (assisted byone or more nurses), who works on a part-time basis inthe hospital and is responsible for detection and evalu-ation of potential donors, and coordinating the entiredonation-transplantation process including family ap-proach. The physician is in close relationship with thetransplant team and the OPC and reports directly tothe Hospital Director. Most of the physicians in thisrole are intensivists, but some other specialists mightbe included.

b. Regional level: regional bodies may help to coordinateprocurement and transplantation at the local level be-tween individual hospitals and with state, provincial, ornational organizations, particularly in the context oflarge populations or geographical boundaries. For ex-ample, there is an administrative office for each of the17 regions in Spain, which together constitute theNational Transplant Commission where technicaldecisions are made and then communicated to a co-ordinator in the relevant hospital.

c. National level: each country that performs transplanta-tion needs to organize a unified coordination networkthat regulates the organ donation and transplantationprocess. National coordination systems essentially pro-vide a support agency for the entire organ donation andtransplantation system. National coordination is con-cerned with organ distribution, transport organization,waiting list maintenance, general and specialized infor-mation, and any policies or actions that can contributeto improved outcomes in the donation transplantationprocess. This support is of utmost importance for smallhospitals that cannot undertake organ donation pro-cesses independently. Quality control for each institu-tion, establishment of allocation rules, collection andanalysis of national data, education, and certificationfor personnel are all coordinated at a national level.

International CoordinationInternational coordination is required to facilitate

cross-border exchange of information and research. It alsomay enable better efficiencies through regional organ sharingprogrammes that can avoid discard of usable organs and ad-dress urgent needs most effectively. International coordina-tion and cooperation also has a critical role in addressing theproblems of organ trafficking and transplant tourism. Exam-ples of international system coordination in organ donationand transplantation include:

a. EIF (http://www.eurotransplant.org/): EIF is responsiblefor the mediation of organ donation procedures and theallocation of donated organs across Austria, Belgium,Croatia, Germany, Luxemburg, The Netherlands, and Slo-venia. This coordination network incorporates all trans-plant hospitals, tissue-typing laboratories, and hospitalswhere donations take place in the participating countries.The aims of EIF are to:

• Achieve optimal use of available donor organs andtissues;

• Secure a transparent and objective allocation system,based on medical and ethical criteria;

• Assess factors influencing waiting-list mortality andtransplant results;

• Support donor procurement and increase the supplyof donor organs and tissues;

• Promote scientific research;• Disseminate and implement EU legislation relevant to

transplantation;• Promote, support, and coordinate organ donation and

transplantation in the broadest sense.

b. Trans Tasman Exchange (http://www.tsanz.com.au/organallocationprotocols/transtasmanexchangeprinciples.asp): TheTrans Tasman agreement between Australia and New Zea-land enables the sharing of organs between these nations’respective populations in particular circumstances. Theagreement is mutually beneficial, with organs that cannotbe used in one country being offered to the other, and incases of urgent need, the saving of a life is prioritized with-out concern for individual nationalities. Concern for eq-

FIGURE 10. Three levels of coordination for national or-gan donation and transplantation programmes and respon-sibilities at each level.


http://www.eurotransplant.org/

http://www.tsanz.com.au/organallocationprotocols/transtasmanexchangeprinciples.asp

http://www.tsanz.com.au/organallocationprotocols/transtasmanexchangeprinciples.asp

uity is reflected in the distributional methods employedbetween the countries.

REFERENCES1. Arnold RM, Siminoff LA, Frader JE. Ethical issues in organ procure-

ment: A review for intensivists. Crit Care Clin 1996; 12: 29.2. WHO Guiding Principles; WHA 63.22/2010. Available at: http://

www.who.int/transplantation/en/.3. Neuberger J, Adams D, MacMaster P, et al. Assessing priorities for

allocation of donor liver grafts: survey of public and clinicians. BMJ1998; 317: 172.

4. Rithalia A, McDaid C, Suekarran S, et al. Impact of presumed consentfor organ donation on donation rates: A systematic review. BMJ 2009;338: a3162.

5. Rithalia A, McDaid C, Suekarran S, et al. A systematic review of pre-sumed consent systems for deceased organ donation. Health TechnolAssess 2009; 13: iii, ix-xi, 1.

6. Jousset N, Gaudin A, Mauillon D, et al. Organ donation in France:Legislation, epidemiology and ethical comments. Med Sci Law 2009; 49:191.

7. Andersen KS, Fox DM. The impact of routine inquiry laws on organdonation. Health Aff (Millwood) 1988; 7: 65.

8. Ross LF, Rubin DT, Siegler M, et al. Ethics of a paired-kidney-exchangeprogram. N Engl J Med 1997; 336: 1752.

9. U.S.Department of Health and Human Services. The organ donationbreakthrough collaborative: Best practices final report (September2003). Nephrol Nurs J 2003; 30: 529.

10. Marks WH, Wagner D, Pearson TC, et al. Organ donation and utiliza-tion, 1995–2004: Entering the collaborative era. Am J Transplant 2006;6(5 pt 2): 1101.

11. Shafer TJ, Wagner D, Chessare J, et al. Organ donation breakthroughcollaborative: Increasing organ donation through system redesign. CritCare Nurse 2006; 26: 33, 44; quiz 49.

12. Matesanz R, Marazuela R, Dominguez-Gil B, et al. The 40 donors permillion population plan: an action plan for improvement of organdonation and transplantation in Spain. Transplant Proc 2009; 41: 3453.

13. Bollinger RR, Heinrichs DR, Seem DL, et al. Organ procurement orga-nization (OPO), best practices. Clin Transplant 2001; 15(suppl 6): 16.

14. Poli F, Scalamogna M, Cardillo M, et al. An algorithm for cadaverkidney allocation based on a multivariate analysis of factors impactingon cadaver kidney graft survival and function. Transpl Int 2000;13(suppl 1): S259.

15. Danovitch GM, Cecka JM. Allocation of deceased donor kidneys: Past,present, and future. Am J Kidney Dis 2003; 42: 882.

16. Wiesner R, Edwards E, Freeman R, et al. Model for end-stage liverdisease (MELD) and allocation of donor livers. Gastroenterology 2003;124: 91.

17. Coombes JM, Trotter JF. Development of the allocation system fordeceased donor liver transplantation. Clin Med Res 2005; 3: 87.

18. Jacquelinet C, Audry B, Pessione F, et al. [Rules for allocation of liversfor transplantation]. Presse Med 2008; 37: 1782.

19. Prottas JM. The organization of organ procurement. J Health PolitPolicy Law 1989; 14: 41.

20. Matesanz R, Miranda B, Felipe C. Organ procurement and renal trans-plants in Spain: The impact of transplant coordination. Spanish Na-tional Transplant Organization (ONT). Nephrol Dial Transplant 1994;9: 475; discussion 479.

21. Roels L, Cohen B, Gachet C, et al. Joining efforts in tackling the organshortage: The Donor Action experience. Clin Transpl 2002: 111.

22. Frist WH, Fanning WJ. Donor management and matching. CardiolClin 1990; 8: 55.

23. Wood KE, Becker BN, McCartney JG, et al. Care of the potential organdonor. N Engl J Med 2004; 351: 2730.

24. Tjabbes H. Donor screening: An overview of current regulation andpractices in Europe. Transplant Proc 1996; 28: 2950.

25. DonorNet http://www.donornet2007.net/DonorNet, new webbasedapplication to increase organ placement, launched by UNOS. Trans-plant News, September 14, 2003; Available at: http://findarticles.com/p/articles/mi_m0YUG/is_17-13/ai_n18617175/

26. Moreno A, et al Finding efficient organ transport routes using multi-agent system. Available at: http://citeseerx.ist.psu.edu/viewdoc/summary?; doi10.1.1.24.3863

27. DuBois JM, Anderson EE. Attitudes toward death criteria and organdonation among healthcare personnel and the general public. ProgTransplant 2006; 16: 65.

28. Matesanz R, Miranda B, de Felipe C, et al. Ecolucion de la donacion y laactividad transplanstadora en Espana. In: El donante de organos y teji-dos: Evaluacion y manejo. Barcelona, Springer Verlag Iberica 1997.

29. Matesanz R, Dominguez-Gil B. Strategies to optimize deceased organdonation. Transplant Rev 2007; 2007: 177.

30. Guidelines for the determination of death: report of the medical con-sultants on the diagnosis of death to the President’s Commission forthe Study of Ethical Problems in Medicine and Biomedical and Behav-ioral Research. JAMA 1981; 246: 2184

31. Merion RM. Expanded criteria donors for kidney transplantation.Transplant Proc 2005; 37: 3655.

32. Steinbrook R. Organ donation after cardiac death. N Engl J Med 2007;357: 209.

33. Organ Shortage: The Solutions. Proceedings of the 26th Conference onTransplantation and Clinical Immunology, June 13–15, 1994. In:Touraine JL, Traeger J, Betuel H, et al., eds. Dordrecht, Kluwer Aca-demic Publishers 1995.

APPENDIX 2: The Critical Pathway forOrgan Donation After Death

Assessing the Potential of Donation fromDeceased Persons and Promoting theIdentification of Potential Deceased OrganDonors (Working Group 3)

Self-sufficiency in transplantation is defined as the sat-isfaction of the transplantation needs of a given population,by using resources obtained from within that population.Donation from deceased persons, realized to its maximumtherapeutic potential within a given population, is an essen-tial element of the self-sufficiency paradigm, as alreadystressed in existing International Standards:

• WHO Guiding Principles for Human Cell, Tissueand Organ Transplantation Guiding Principle 3 (1):

“Donation from deceased persons should be developed toits maximum therapeutic potential”

The principle emphasizes the importance of both tak-ing the legal and logistical steps needed to develop deceaseddonor programmes where they do not exist, and making ex-isting programmes as effective and efficient as possible.

• The Declaration of Istanbul on Organ Trafficking andTransplant Tourism (2):

“Governments, in collaboration with health-care institu-tions, professionals, and NGOs, should take appropriateactions to increase deceased organ donation . . . Incountries without established deceased organ donationor transplantation, national legislation should be enactedthat would initiate deceased organ donation and createtransplantation infrastructure, so as to fulfill each coun-try’s deceased donor potential. In all countries in whichdeceased organ donation has been initiated, the therapeu-tic potential of deceased organ donation and transplanta-tion should be maximized.”

A SYSTEMATIC APPROACH TO THEPROCESS OF DONATION FROM

DECEASED PERSONSTo develop and maximize organ donation activities, an

organizational approach to donation from deceased persons




http://www.donornet2007.net/DonorNet


should be adopted. Donation from deceased persons is a pro-cess (A process is a set of correlated activities, which convertan input into an output by generating an added value[UNIEN ISO 9000:2000]), involving a set of steps at each ofwhich losses of potential deceased organ donors can occur.One of the weakest links of this chain is the failure to identifyand subsequently refer potential deceased organ donors. Asystematic approach to the process of donation from de-ceased persons will help populations to define actions, roles,and responsibilities within the process, tailored to their localcircumstances. This systematic approach should considerboth DBD and DCD.

Estimating the Potential of Organ Donation FromDeceased Persons

In the pursuit of self-sufficiency, estimating the poten-tial of organ donation from deceased persons within a popu-lation is essential.

• It facilitates understanding of the local possibilities forsatisfying the transplantation needs of that population.

• It allows a better comprehension of those factors actingat a hospital, regional, or national level, whatever theirnature, that affect the potential of donation from de-ceased persons within a given population and hence or-gan donation and transplantation outcomes.

• It is crucial to evaluate performance in the process ofdonation from deceased persons within a specific geo-graphical location, at a hospital, a regional, or a countrylevel. Performance evaluation is necessary to formulaterelevant policies and standards of practice and to discernachievable goals for organ donation programmes,through the identification of the best performers andcritical success factors (benchmarking), and evaluationof the effectiveness of implemented strategies.

Evaluation of performance in organ donation, espe-cially when comparing countries or regions, has been classi-cally addressed by comparing numbers of deceased donorsper million population. This is a universal, objective, andeasy-to-construct metric of performance. However, it hasbeen considered flawed, because it assumes that the potentialof organ donation from deceased persons is uniform acrossall jurisdictions under assessment. It fails to capture perfor-mance in the context of rates of mortality under conditionssuitable for organ donation. Many local factors will affect thisfinal number, including demography, mortality in the con-text of brain injury, accessibility to the hospital, cultural,healthcare system, and organizational factors, among others(3, 4). Even when severely brain damaged patients are able toaccess a hospital, many other factors will determine whether,if the person finally dies, this occurs under conditions suitablefor organ donation. Such factors include, for example, thesufficient availability of intensive care resources or variabilityin clinical practice in the treatment of neurocritical patientsand in terminal care.

When estimating the potential of organ donation fromdeceased persons, two different, although potentially com-plementary, approaches may be adopted:

• A retrospective approach, based on the analysis of mor-tality data or, ideally, through a clinical chart review of

deaths occurring within a specific setting to identify po-tential donors.

• A prospective approach, through the systematic identi-fication and referral of persons dying in conditions suit-able for organ donation.

These strategies have been applied in different settingsand have been frequently combined for better estimation ofthe potential of organ donation from deceased persons andaccurate evaluation of performance.

Use of Mortality Data to Estimate the Potential ofDonation From Deceased Persons

The use of mortality data is considered an objective,cheap, and nonlabor intensive approach to the estimation ofthe potential of donation from deceased persons. This esti-mation may be based on general mortality data or in-hospitaldeaths. Some selection criteria may be applied to any of thesedata, based on the inclusive factors (conditions potentiallyleading to a severe brain injury or circulatory failure) andexclusive factors (absolute medical contraindications to or-gan donation). These approaches have been used to generatenationwide estimations of the potential of donation from de-ceased persons in the United States (5) and the Europeansetting (6).

In the US study, performance was evaluated for eachof the different UNOS regions based on Donor ExtractionRate, calculated as the number of actual donors aged 1 to65 years over the number of evaluable deaths (in-hospitaldeaths for ages 1 to 65 years, not medically unsuitable,based on the ICD-9 codes). Notably, results of this studywere comparable with previous approaches based on a de-tailed review of medical records of in-hospital deaths (5).Coppen et al. recently compared the performance of de-ceased donation processes across several European coun-tries, based on the calculation of ‘Donor Efficiency Rateper Proxy’ (actual donors vs. deaths because of cardiovas-cular and traffic accidents), as the rate of mortality becauseof these causes was found to bear a high correlation withdeceased donation activity (6).

However, attempts to work with mortality data faceseveral limitations given that these data are usually notreadily available, death certificate data are restricted by theinherent problems of underreporting and codification er-rors, and codification of deaths is not a universally imple-mented practice.

Prospective Identification and Referral ofPotential Donors and Clinical Chart Review

Studies of donation potential, based on prospectiveidentification or clinical chart review, have been performed inseveral countries and enable a good comprehension of de-ceased donation performance in those settings for which es-timates are available (Fig. 11).

Both methodologies (prospective identification ofpotential donors and clinical chart reviews) have the ad-vantages of being sensitive to local variation in factors thataffect the potential of donation in a given population, al-lowing analysis of an individual’s suitability for organdonation, and facilitating the identification of areas forimprovement in deceased donation processes. However,


the fact that these methodologies are not standardized at auniversal level limits international comparisons of de-ceased donor potential. Table 6 describes in detail thedesign of a selection of international studies estimatingnational donation potential. Notably, the definition of apotential donor varies greatly between these studies. Inaddition, most of these studies are based on a self-report-ing, prospectively or retrospectively, performed by profes-sionals in charge of the process of donation from deceasedpersons. Hence, estimates of donation potential rely on thedegree of referral and identification of potential donors,which may vary depending on the motivation and experi-ence of the health professional in charge. Constructingcombined indicators of potential of donation from de-ceased persons, based on self-reported data on one handand mortality data on the other hand, has been proposed asa good approach for a more realistic comprehension of thepotential of donation and as a metric of performance indonor identification (7).

As an example of the application of these methods inprogramme evaluation, the performance of different OPOs inthe United States is evaluated according to Donation Rate,whereby the number of actual donors meeting a set of eligi-bility criteria is compared with the number of eligible deaths(�70 years, ultimately legally declared brain dead and withno medical contraindications to organ donation). This metricrepresents the performance of a particular OPO with respectto the conversion of potential donors, once identified, into

actual donors (3). Eligible deaths are communicated prospec-tively from hospitals to OPOs by self-report, potentially in-troducing bias because of an underreporting. To gain a betterunderstanding of overall performance, Ojo et al. (3) proposeda complementary Notification Rate metric, according towhich the number of eligible deaths was to be comparedagainst the number of notifiable deaths, this number beingestimated on the basis of in-hospital mortality data with someinclusive and exclusive factors (through the analysis of ICD-9codes) as mentioned earlier.

Clinical chart review of deceased persons within a par-ticular setting is considered the gold standard for accuracy inthe assessment of donation potential, especially if performedby external observers. However, it has been considered costlyand time consuming by some commentators. Others haverecommended the systematic and routine performance ofclinical chart reviews by those professionals in charge of thedeceased donation process, as an essential tool for a continuousimprovement in performance (8, 9). Quality assurance pro-grammes based on this approach have been developed in differ-ent countries and are considered an essential element of successin many models (10). Based largely on self-report, informationprovided by these quality assurance programmes may be com-plemented by external audits of centers or by the construction ofindicators, which combine information collected based on self-reporting methods with mortality data.

Given wide international variation in approaches to or-gan donation processes, the provision of an internationally

FIGURE 11. Countries with published information on the potential of deceased donation, estimated through prospectiveidentification-referral or clinical chart review (13-33).



applicable reference framework for systematizing donationfrom deceased persons, together with guidelines for interna-tionally consistent methods and metrics for estimation of do-nation potential and evaluation of donation performance,

will facilitate the development of consistent, integrated orga-nizational approaches to organ donation, and thus advancethe pursuit of self-sufficiency worldwide. Moreover, com-mon international approaches to donation processes andtheir evaluation will help to overcome the inherent difficul-ties of international comparisons, needed for transparency ofpractices and outcomes, international benchmarking, andmutual learning.

THE CRITICAL PATHWAY FOR ORGANDONATION FROM DECEASED PERSONS

ObjectivesThe principal objective of a Critical Pathway ap-

proach to the process of donation from deceased persons isto facilitate the development, and progressive increase, ofdeceased donation activities globally. This objective is cen-tral to the broader goal of self-sufficiency in transplanta-tion and may be broken down into the following specificobjectives:

a. To provide a common systematic approach to the pro-cess of donation from deceased persons, both for DBDand DCD;

b. To create common triggers to facilitate the prospectiveidentification and referral of the potential deceased or-gan donor and precipitate the deceased donation pro-cess (action);

c. To provide common procedures to estimate the poten-tial of organ donation from deceased persons and toevaluate performance in the process of donation afterdeath (assessment).

MethodologyTo achieve the objectives above, TTS, WHO, and

ONT convened a group of experts, widely representative ofthe different WHO regions, on three different occasions(Sydney, Australia, August 2008; Geneva, Switzerland,March 2009; and Berlin, Germany, October 2009), to drafta Global Consensus Document providing specific recom-mendations in this regard. This draft was finalized duringthe Third WHO Global Consultation on Organ Donationand Transplantation (Madrid, Spain, March 2010) byWorking Group 3.

The guidelines provided to the group for the construc-tion of these recommendations were:

a. Recommendations were to be based on the current sci-entific knowledge, experience from existing runningprocedures and systems, interaction, mutual learning,and agreement between the different countries;

b. Recommendations were to be conceived in a way thatthe methodology should be applicable to every countryor region, regardless of the level of development of itshealthcare system or the baseline situation of its de-ceased donation activity.

During the past year, the draft recommendations withregards to the structure of the deceased donation process,assessment of the potential of donation from deceased per-sons, and provision of clinical triggers for the identificationand referral of potential donors have been piloted in different

TABLE 6. National estimations of the potential ofdonation based on the prospective identification andreferral of potential donors or on a clinical chart review

Ploeg, The Netherlands (29)Scope 11 hospitals (convenient selection

of different types of hospitals)

Design Prospective assessment

Data collection

Performed by Physicians declaring death

Performed on Hospital deaths

Definition of a potentialdonor

No MC, below an age threshold(maximum); diagnosis possiblyleading to BD (optimistic);artificial ventilation; and BDdeclared (realistic)

Inferred national estimates Actual donors, consented donors,and number of hospitals ofeach type

Sheehy, United States (12)Scope 25–36 OPOs (convenient

selection)

Design Retrospective clinical chart review

Data collection

Performed by Trained staff members of OPOs

Performed on ICU deaths

Definition of a potentialdonor

No absolute MC, aged �70 yearsand met criteria for BD

Inferred national estimates Actual donors, population

Barber, United Kingdom (14)Scope All ICU with a potential for DBD

Design Retrospective

Data collection

Performed by Donor transplantcoordinators/donor liaison nurses/some ICU link nurses


Definition of a potential donor No absolute MC and brain stemdeath declared

Inferred national estimates —

QAP, Spain (2007)a

Scope Donor hospitals (75%,convenient selection)

Design Retrospective

Data collection

Performed by Transplant coordinators


Definition of a potential donor No MC and met criteria for BD

Inferred national estimates Actual donors

a Quality assurance programme in the deceased donation process.ONT website.

MC, medical contraindications; BD, brain death; OPO, organ procurementorganization; ICU, intensive care unit; DBD, donation after brain death.


settings—India (Dr. Vivekanand Jha), Russia (Dr. MarinaMinina), Saudi Arabia (Dr. Faisal Shaheen), and South Africa(Dr. Elmi Muller). These pilot experiences have shown therecommendations to be applicable and beneficial in each ofthe settings in which they were applied, with increasesdemonstrated in the identification and referral of potentialdeceased organ donors as a result of implementation. Theoutcomes of these pilot experiences were presented duringthe combined ISODP-ETCO congress, celebrated in Berlin inOctober 2009.

Recommended Structure for the Process ofDeceased Donation: The Critical Pathway

The process of organ donation from deceased personsdefined in this project is described under The Critical Path-way for organ donation. Pathways are described for bothDBD and DCD.

The process of organ donation from deceased personsdeveloped by the work group is graphically represented inFigure 2. The processes of DBD and DCD are describedbelow:

a. Possible deceased organ donor• A possible deceased organ donor is defined as the patient

with a devastating brain injury or lesion or the patientwith circulatory failure and apparently medically suit-able for organ donation

• Identification of the possible deceased donor and re-ferral by the treating physician to a key donation per-son/OPO should ideally occur as early as possible inthe process. For example, in the United States, eachimminent death should be referred to the OPO forassessment (where imminent may be understood asthe time of transition between therapeutic treatmentsto end-of-life care). However, referral of the possibledonor might not be acceptable in all local circumstances(i.e., many countries do not find it acceptable to refer pos-sible donors where death has not yet been established).Hence, it is accepted that referral might occur later on inthe process of donation from deceased persons. It shouldbe pointed out that referral is understood as the action ofmaking the key donation person/OPO aware of the pos-sibility of deceased donation, but it does not meanany other subsequent action. Referral requires, and islinked to, the act of identification.

• The possible deceased organ donor when defined as thepatient with a devastating brain injury represents the com-mon starting point of two different pathways that activatedepending on evolution and clinical practice: the process ofDBD and the process of DCD. The possible donor definedas the patient with circulatory failure might be the startingpoint of the process of DCD.

b. The process of DBD• A potential donor after brain death (DBD) is defined as

a person whose clinical condition is suspected to fulfillbrain death criteria.

• A potential DBD would become an eligible donor af-ter brain death if the person is considered medically

suitable for organ donation and is declared deadbased on neurologic criteria, as stipulated by the lawof the relevant jurisdiction. Regarding medical suit-ability, it should be acknowledged that medical con-ditions precluding organ donation might vary be-tween countries according to legal and technicalprovisions. The reasons why a potential DBD does notbecome eligible for donation might be the following:(1) failure to identify and subsequently refer the case(if this is the point for referral, according to localcircumstances); (2) presence of medical conditionsprecluding organ donation; (3) the diagnosis of braindeath cannot be confirmed or completed (i.e., because ofthe lack of technical or human resources necessary for con-firmation); or (4) hemodynamic instability leading to ananticipated cardiac arrest. The three last situations couldstill be linked to the possibility of controlled or uncon-trolled DCD.

• An eligible DBD would become an actual donor after braindeath only after consent has been obtained for organ dona-tion. Two possible situations define the actual DBD. Thefirst situation would be that in which an operating incisionhas been made with the intent of organ recovery for thepurpose of transplantation. In the second situation, thecondition of actual donation would be defined whenat least one organ has been recovered for transplanta-tion purposes. The evolution from eligible to actual do-nor entails the need to obtain permission for organ do-nation, although such permission might have beenobtained at an earlier stage during the process, accord-ing to the legal framework and practical provisions inplace. Also, according to local circumstances, permis-sion might be based on the expression of the deceasedduring his/her lifetime (i.e., through a specific regis-try) or might be obtained from their relatives. Autho-rization by a coroner or other judicial officer to allowdonation for forensic reasons, if applicable, mightalso be needed at a certain point. Continuous evalua-tion of medical suitability for organ donation, hemo-dynamic maintenance of the donor, organ allocation,and the finally surgical incision and organ recoveryare all necessary steps in the transition from eligible toactual DBD. Losses because of maintenance problemswould still be linked to the possibility of uncontrolledDCD.

• Finally, a utilized donor after brain death would bethe actual DBD from whom at least one organ hasbeen transplanted, followed by organ allocation andtransplantation itself. Organ damage during recovery,anatomical, histologic and functional abnormalitiesof the organs detected during or after recovery, inad-equate perfusion/thrombosis of the organs, logisticalproblems, and lack of an appropriate recipient are thecategorical reasons why an actual DBD does not be-come a utilized DBD.

b. The process of DCD• Two conditions deriving from the possible deceased organ

donor could define the potential donor after circulatorydeath. A person whose circulatory and respiratory func-tions have ceased and in whom resuscitative measures are



not to be attempted or continued would define the first ofthese two conditions. DCD under these particular cir-cumstances is so far limited to some specific countries(i.e., France, Spain), although possible to be devel-oped in many other settings.

• The second condition defining a potential donor after cir-culatory death would be that of the patient in whom thecessation of circulatory and respiratory functions is antici-pated to occur within a time frame that will enable organrecovery. This situation usually applies when withdrawal oflife-supporting therapy has been decided on the basis of theominous prognosis of the patient, pursuant to the familydecision, or the request of the family. It should be pointedout that there are an additional small number of patientswho would fulfill these criteria of potential DCD but with-out brain injury, that is, end-stage lung disease patientswith elective withdrawal of ventilatory support or patientswith progressive neurodegenerative diseases such as amyo-trophic lateral sclerosis with elective withdrawal of life-sus-taining therapy.

• A potential DCD would become an eligible donor aftercirculatory death when the person is considered medicallysuitable for donation and has been declared dead based onthe irreversible absence of circulatory and respiratory func-tions as stipulated by the law of the relevant jurisdiction,within a time frame that enables organ recovery. The stepsrequired for a potential DCD becoming an eligible DCDwould be: (1) the identification and subsequent referral ofthe case for organ donation (if not previously performed);(2) the declaration of death by circulatory and respiratorycriteria within an appropriate time frame that allows organrecovery, (3) the consent to proceed with organ recovery(this may occur before or during the process according tolocal legislation), and (4) evaluation of the medical suitabil-ity for donation.

• An eligible DCD would become an actual donor after cir-culatory death if an incision has been made fororgan recovery and at least one solid organ has been recov-ered for the purpose of transplantation. This requires atleast continuous medical evaluation, organ allocation andrecovery. Reasons why an eligible DCD does not becomean actual DCD are as for the process of DBD.

• A utilized donor after circulatory death is defined as theactual DCD from whom at least one organ has been trans-planted. Organ allocation and transplantation are the con-version steps in this process. The same categorical reasonsas those described for the process of DBD justify that anactual DCD not be converted to a utilized DCD.

Recommendations for the ProspectiveIdentification and Referral of the PotentialDeceased Organ Donor

Identification and referral of the potential deceased organdonor is one of the most critical steps in the realization of dona-tion after death. Identification of a potential deceased organ do-nor should be inherently linked to the act of referral to a keydonation person/transplant coordinator/OPO specifically ap-pointed for the activation of the deceased donation process. Theact of referral means informing these key organ donation per-sonnel of an individual that could be a possible, a potential or aneligible organ donor, according to the pathway described above.

When should the referral occur?

• For DBD: at a minimum, when the Critical Pathway es-tablishes an eligible donor.

• For DCD: at a minimum, when the Critical Pathwayidentifies a potential donor.

• For DBD and DCD: referral could also occur when theCritical Pathway establishes a possible donor; or

• Referral may also occur when the family requests tospeak with the OPO/key organ donation personnel.

RECOMMENDED METHODOLOGY FORTHE RETROSPECTIVE ASSESSMENT OF

THE POTENTIAL OF ORGAN DONATIONFROM DECEASED PERSONS

Retrospective assessment of the potential of organdonation from deceased persons for the purposes of pro-gramme evaluation must consider all possible donors, po-tential donors, and eligible donors. The basic methodologyfor such estimations is based on coded mortality data orclinical chart review.

Estimating the Number of Possible DeceasedOrgan Donors

The number of possible deceased organ donors, par-ticularly those with a devastating brain injury, may be es-timated from the analysis of coded mortality data. Thiscoded mortality data would identify those deaths mostlikely to become donor candidates or would identify de-ceased patients with a diagnostic code consistent withbrain injury or lesion.

On the basis of mortality data, therefore, the possibledeceased organ donor would be identified as a person dyingwithin a hospital with primary or secondary brain damage,defined by the presence of at least one of the ICD codes rep-resented in Table 7 among their primary and secondary diag-noses (7). Alternatives to this codified mortality system havebeen applied in other countries (e.g., death with acute cere-bral lesion in Italy).

Estimating the number of possible deceased organ donorson the basis of codified mortality data has the following caveats:

• Persons dying with primary or secondary brain dam-age may have not died as a consequence of the braininjury;

• The ICD system is not universally applied in all the coun-tries, regions, or hospitals, or in all critical care units;

• Coded mortality data are not readily available;• Contrary to clinical chart review, it does not allow the

complementary analysis of the particular reasons whya potential donor did not become an actual donor,thus mortality data have limited usefulness as a toolfor the evaluation of the performance of deceased do-nation programmes.

Estimating the Number of Potential and EligibleDeceased Organ Donors After Brain Death

The number of potential and eligible donors, in contrast,is necessarily obtained from a clinical chart review. The mostcritical aspect of estimating the number of potential and eligible


deceased donors in a particular setting is the evaluation of braindeath, in particular with regard to the identification of the clini-cal condition of brain death (there is at least one physical exam-ination compatible with brain death) and the declaration ofbrain death (the diagnosis of brain death has been completedaccording to international standards and legally declared). How-ever, as clinical chart review relies on the recording of completeand reliable chart data, for the purposes of appraising whether aperson fulfils the criteria of brain death, it would be necessary toagree on standard minimum data requirements for hospitalcharts. Two examples of minimum data requirements are pro-vided below ([12]; methodology of the Spanish Quality Assur-ance Programme in the donation process).

Metrics to Represent the Potential of DonationProposed metrics by which to perform comparisons of

the potential of donation from deceased persons are outlinedin Table 8.

RECOMMENDATIONS FOR THEEVALUATION OF THE PERFORMANCE IN

THE DECEASED DONATION PROCESSThis section intends to provide a set of definitions and

metrics that represent performance in the deceased donationprocess. These metrics, which describe the overall perfor-mance of the system, will facilitate the identification of criticalsuccess factors.

Suggested Additional Definitions

a. Multiorgan donors: donors from whom at least two dif-ferent types of organs have been recovered for the purposeof transplantation as a solid organ.

b. Organs recovered per donor: number of different organs thathave been recovered from actual donors. To calculate the num-ber of organs recovered, only organs recovered with the inten-tion of transplantation as a solid organ should be counted.

• Number of kidneys recovered: double procurement, 2;single procurement, 1.

• Number of livers recovered: exclude if the intention ofrecovery is not transplantation as a solid organ (i.e.,hepatocytes).

• Number of hearts recovered: exclude if the intention ofrecovery is not transplantation as a solid organ (i.e.,heart valves).

• Number of lungs recovered: double procurement, 2;single procurement, 1.

• Number of pancreas recovered: exclude if the intention of re-covery is not transplantation as a solid organ (i.e., islets).

• Number of small bowel procured.

c. Organs transplanted per donor: number of different or-gans that have been transplanted from actual donors. Tocalculate the number of organs transplanted, only solidorgans should be counted.

• Number of kidneys transplanted: double transplanta-tion, 2; single transplantation, 1.

• Number of livers transplanted: count one, regardless ofspecific use of the organ (i.e., split liver transplantation).

• Number of hearts transplanted.• Number of lungs transplanted: double transplantation,

2; single transplantation, 1.• Number of pancreas transplanted.• Number of small bowel transplanted.

Suggested Metrics of PerformancePerformance in the deceased donation process may be

represented as indicated in Table 9.

Representing Performance at a Regional or at aCountry Level According to DifferentAvailability of Data

The number of possible donors at a regional/country levelmay be estimated based on a top-down approach to infer theperformance of the deceased donation processes for a given re-gion or country. Possible methodologies are described below:

a. Living population : deaths within the country/region.b. Deaths within the country/region because of selected

pathologies: (crude) deaths because of cerebrovascularaccidents and traffic accidents.

TABLE 7. ICD-9 codes representing the most frequentcauses of brain death

ICD-9 Description

Cranioencephalic traumatisms800 Fracture of vault of skull

801 Fracture of base of skull

803 Other and unqualified skull fractures

804 Multiple fractures involving skull or facewith other bones

850 Concussion

851 Cerebral laceration and contusion

852 Subarachnoid, subdural, and extraduralhemorrhage after injury

853 Other and unspecified intracranialhemorrhage after injury

854 Intracranial injury of other andunspecified natures

Cerebrovascular accidents430 Subarachnoid hemorrhage

431 Intracerebral hemorrhage

432 Other and unspecified intracranialhemorrhage

433 Occlusion and stenosis of precerebralarteries

434 Occlusion of cerebral arteries

436 Acute, but ill-defined, cerebrovasculardisease

Tumors of the central nervous system191 Malignant neoplasm of brain

192 Malignant neoplasm of other andunspecified parts of nervous system

225 Benign neoplasm of brain and other partsof nervous system

Cerebral anoxia348.1 Anoxic brain damage

ICD, international classification of disease.



Criteria applied at the Spanish Quality Assurance Programme in the deceased donation process Four concepts are applied: confirmed brain death, highly probable brain death, possible brain death, and not assessable brain death. 1. Confirmed brain death: For the purposes of the programme, a person will be considered as a confirmed brain death if any of the

a. All legal requirements are properly reflected in the chart. b. A neurologist or neurosurgeon has explored the dead person and has recorded that brain death has occurred and there is no

evidence against this diagnosis. c. ICU physician has recorded that brain death has occurred and there is no evidence against this diagnosis.

To define a person as being a highly probable or a possible brain death, the following issues are considered based on the available information in the clinical chart:

a. Etiology of the process causing death: It must be one of the known etiologies that cause brain death and must be severe enough to cause it.

b. Conditions: absence or no evidence of spontaneous breathing and movements. c. Findings in clinical exploration:

• Progressing nonreactive midriasis (de novo nonreactive midriasis in a patient with severe neurologic pathology, in the context of a severe clinical deterioration and which is not explained by drug interference)

• Absence of at least one of the following brain-stem reflexes: corneal, oculocephalic, oculovestibular, coughing, and gag.

• Negative atropine test. d. Clinical signs:

• Abrupt arterial hypotension, other causes apart from brain death having been discarded. • Abrupt polyuria, other causes having been discarded. • Refractory and progressive intracranial hypertension (intracranial hypertension which progresses in the minutes

or hours before death, towards limits that provoke a cerebral perfusion pressure of 0 or close to 0 mm Hg, with no response to therapy).

2. Highly probable brain death: Etiology + conditions + 1 finding (at least) in clinical exploration + 1 clinical sign (at least) Etiology + conditions + 2 findings (at least) in clinical exploration

3. Possible brain death: Etiology + conditions + 1 finding in clinical exploration (at least) Etiology + conditions + 1 clinical sign (at least)

4. Finally, brain death will not be assessable in any of the following circumstances: a. Etiology of the process is known, severe and consistent with brain death, in the absence of any more information in the

clinical chart or absence of clinical chart. b. Etiology of the process is known, severe, and can lead to brain death, but diagnosis could not be confirmed because of a

limitation of the therapeutic effort. c. Etiology of the process is known, severe, and can lead to brain death, but exposure to barbiturics, muscle relaxant drugs at the

moment of cardiac arrest is present. d. Infratentorial processes with no legal diagnosis of brain death.

Any other situation will be considered as no brain death.

Criteria applied by Sheehy et al. to the potential donor after brain death (12):

A deceased person for whom evidence of all or any of the following is found in the hospital chart: � the absence of spontaneous respiration and two additional brain-stem reflexes, � a physician’s note declaring brain death, � a flat electroencephalogram, � or other brain studies indicating irreversible destruction of the brain.

following circumstances are present:

TABLE 8. Proposed metrics to represent the potentialof donation

Possible deceased organ donors/hospital deaths�100

Potential donors after brain death/possible deceased organdonors�100

Potential donors after circulatory death/possible deceased organdonors�100

Potential donors after circulatory death/potential donors afterbrain death�100

TABLE 9. Indicators of performance in the deceaseddonation process

Actual donors/possible donors�100

Actual donors/potential donors�100

Actual donors/eligible donors�100

Multiorgan donors/actual donors�100

Utilized donors/actual donors�100

Organs recovered/donor

Organs transplanted/donor


c. In-hospital deaths within the country/region.d. In-hospital deaths within the country/region because of

selected pathologies: In-hospital deaths with brain in-jury, on the basis of at least one of the ICD-9 codesspecified in Table 7 among their primary and secondarydiagnosis (i.e., possible deceased organ donors).

The number of potential and eligible donors for a givenregion or country could be estimated for countries in which a clin-ical chart review is performed at all hospitals meeting some specificcriteria (acute care hospitals, hospitals authorized for organ pro-curement). In addition, if information is not available for allhospitals meeting some specific criteria, estimation mightbe performed for a given region/country by inference ac-cording to a given parameter.

REFERENCES1. WHO Guiding Principles; WHA 63.22/2010. Available at: http://

www.who.int/transplantation/en/.2. Steering committee of the Istanbul Summit. Organ trafficking and trans-


3. Ojo AO, Pietroski RE, O’Connor K, et al. Quantifying organ donationrates by donation service area. Am J Transplant 2005; 5(4 pt 2): 958.

4. Cuende N, Cuende JI, Fajardo J, et al. Effect of population aging on theinternational organ donation rates and the effectiveness of the dona-tion process. Am J Transplant 2007; 7: 1526.

5. Ojo AO, Wolfe RA, Leichtman AB, et al. A practical approach to eval-uate the potential donor pool and trends in cadaveric kidney donation.Transplantation 1999; 67: 548.

6. Coppen R, Friele RD, Gevers SK, et al. The impact of donor policies inEurope: a steady increase, but not everywhere. BMC Health Serv Res2008; 8: 235.

7. Procaccio F, Rizzato L, Ricci A, et al. Indicators of efficiency in potentialorgan donor identification: Preliminary results from the national reg-istry of deaths with acute cerebral lesions in Italian intensive care units.Organs Tissues Cells 2008; 2: 125.

8. Recommendation Rec. (2006) 16 on quality improvement program-memes for organ donation; Available at: https://wcd.coe.int/ViewDoc.jsp?id1062721

9. Guide of recommendations for Quality Assurance Programmes in thedeceased donation process. DOPKI website. Available at: http://www.dopki.eu. Accessed February 2010.

10. Roels L, Spaight C, Smits J, et al. Donation patterns in four Europeancountries: Data from the donor action database. Transplantation 2008;86: 1738.

11. Cuende N, Sanchez J, Canon JF, et al. Mortalidad hospitalaria enunidades de críticos y muertes encefalicas segun los codigos de laClasificacion Internacional de Enfermedades. Med Intensiva 2004;23: 1.

12. Sheehy E, Conrad SL, Brigham LE, et al. Estimating the number ofpotential organ donors in the United States. N Engl J Med 2003; 349:667.

13. Aldawood A, Al Qahtani S, Dabbagh O, et al. Organ donation afterbrain-death: Experience over five-years in a tertiary hospital. Saudi JKidney Dis Transpl 2007; 18: 60.

14. Barber K, Falvey S, Hamilton C, et al. Potential for organ donation inthe United Kingdom: Audit of intensive care records. BMJ 2006; 332:1124.

15. Bednarek T. [Application of the donor action program to assess thedonating potential of the intensive care unit at the hospital inKołobrzeg]. Ann Acad Med Stetin 2004; 50: 11.

16. Broomberg CJ, McCurdie FJ, Kahn D. Prospective audit of deaths at ateaching hospital. Transplant Proc 2005; 37: 556.

17. Bustos JL, Surt K, Soratti C. Glasgow coma scale 7 or less surveillanceprogram for brain death identification in Argentina: Epidemiology andoutcome. Transplant Proc 2006; 38: 3697.

18. Christiansen CL, Gortmaker SL, Williams JM, et al. A method for esti-mating solid organ donor potential by organ procurement region. Am JPublic Health 1998; 88: 1645.

19. Cloutier R, Baran D, Morin JE, et al. Brain death diagnoses and evalu-ation of the number of potential organ donors in Quebec hospitals. CanJ Anaesth 2006; 53: 716.

20. Cuende N, Canon JF, Alonso M, et al. Results of the period 1998 –2001 of the ONT quality control programme. Nefrologia 2003;23(suppl 5): 68.

21. Dösemeci L, Yilmaz M, Cengiz M, et al. Brain death and donor man-agement in the intensive care unit: Experiences over the last 3 years.Transplant Proc 2004; 36: 20.

22. Guterres de Abreu AL, Moura da Silva AA, Ferreira R. Estimate of thepotential number of cadaveric donors and availability of organs andtissues for transplants in a capital of the Northeast of Brazil. J BrasNefrol 2006; 28: 23.

23. Madsen M, Bøgh L. Estimating the organ donor potential in Denmark:A prospective analysis of deaths in intensive care units in northernDenmark. Transplant Proc 2005; 37: 3258.

24. Moller C, Welin A, Henriksson BA, et al.; Swedish Council for Organand Tissue Donation. National survey of potential heart beating solidorgan donors in Sweden. Transplant Proc 2009; 41: 729.

25. Nathan HM, Jarrell BE, Broznik B, et al. Estimation and characterization ofthe potential renal organ donor pool in Pennsylvania. Report of the Penn-sylvania Statewide Donor Study. Transplantation 1991; 51: 142.

26. Opdam HI, Silvester W. Identifying the potential organ donor: Anaudit of hospital deaths. Intensive Care Med 2004; 30: 1390.

27. Opdam HI, Silvester W. Potential for organ donation in Victoria: Anaudit of hospital deaths. Med J Aust 2006; 185: 250.

28. Pestana JO, Vaz ML, Delmonte CA, et al. Organ donation in Brazil.Lancet 1993; 341: 118.

29. Ploeg RJ, Niesing J, Sieber-Rasch MH, et al. Shortage of donation de-spite an adequate number of donors: A professional attitude? Trans-plantation 2003; 76: 948.

30. Pokorna E, Vitko S, Ekberg H. Medical-record review of potential do-nor pool in the Czech Republic suggests a possible increase to morethan double the number of donors. Transpl Int 2003; 16: 633.

31. Procaccio F, Barbacini S, Meroni M, et al. Deaths with acute cerebrallesion and heart-beating potential organ donors in the Veneto region.Minerva Anestesiol 2001; 67: 71.

32. Pugliese MR, Degli Esposti D, Dormi A, et al. Improving donoridentification with the Donor Action programme. Transpl Int 2003;16: 21.

33. Wesslau C, Grosse K, Kruger R, et al. How large is the organ donorpotential in Germany? Results of an analysis of data collected on de-ceased with primary and secondary brain damage in intensive care unitfrom 2002 to 2005. Transpl Int 2007; 20: 147.





http://www.dopki.eu

http://www.dopki.eu


GLOSSARY OF TERMS

Actual deceased organdonor

Deceased person in whom an operative incision was made with the intent of organ recovery for the purpose oftransplantation or from whom at least one organ was recovered for the purpose of transplantation(see Critical Pathway)

Critical Pathway Working Group, Madrid Consultation

Allocation The assignment of human cells, tissues, and organs to a transplant candidate, based on a set of rulesWHO Glossary

Authorization Authorization, accreditation, designation, licensing or registration, depending on the concepts used and thepractices in place in each jurisdiction

Adapted from EU Directive 2010

Bank See tissue establishment

Brain death Irreversible cessation of cerebral and brain stem function; characterized by absence of electrical activity in thebrain, blood flow to the brain, and brain function as determined by clinical assessment of responses. A braindead person is dead, although his or her cardiopulmonary functioning may be artificially maintained forsome time

Glossary of UNOS

Bridge therapy See organ replacement therapy

Certification of death Formal standardization documentation of deathWHO Glossary

Circulatory death Death resulting from the irreversible cessation of circulatory and respiratory function; an individual who isdeclared dead by circulatory and respiratory criteria may donate tissues and organs for transplantation

Adapted from the WHO Glossary

Consent to donation Legally valid permission for removal of human cells, tissues, and organs for transplantationWHO Glossary

Death diagnosis Confirmation of death from evidence acquired through clinical investigation or examination, meeting criteriaof brain or circulatory death

WHO Glossary

Distribution Transportation and delivery of cells, tissues or organs intended for human applications, after they have beenallocated

WHO Glossary

Donation Donating human cells, tissues or organs intended for human applicationsWHO Glossary

Donor A human being, living or deceased, who is a source of cells, tissues or organs for the purpose of transplantationWHO Glossary

Donor characterization The collection of the relevant information on the characteristics of the donor needed to evaluate his or hersuitability for organ donation, in order to undertake a proper risk assessment and minimize the risks for therecipient, and optimize organ allocation

EU Directive 2010

Donor evaluation The procedure of determining the suitability of a potential donor, living or deceased, to donateWHO Glossary

Donor maintenance The process and critical pathways used to medically care for donors in order to keep their organs viable untilorgan recovery can occur

WHO Glossary

Donor safety A minimization of living donor complications or adverse reactions related to donationWHO Glossary

Eligible deceased organdonor

A medically suitable person who has been declared dead as stipulated by the law of the relevant jurisdiction,based on neurologic criteria or based on the irreversible absence of circulatory and respiratory functionswithin a time frame that enables organ recovery (see Critical Pathway)


Ethics committee Committee charged with considering ethical issues related to the process of organ procurement, distribution,transplantation, pre-donation and post-donation, and transplantation care and research for cells, tissues andorgans. Such a committee should be at a national level but can also be at a regional or local level

WHO Glossary

Explicit consent Legally valid permission for removal of human cells, tissues and organs for transplantation, otherwise knownas “opting in”

WHO Glossary

(Continued)


GLOSSARY OF TERMS Continued

Exported/export Human bodies, body parts, cells, tissues or organs for human application, legally procured inside of thenational boundary and transported to another country where it is to be further processed or used. Exportmust be according to local (exporting country) laws, international laws and conventions and receivingcountry laws

WHO Glossary

Follow-up Subsequent examinations of a patient, living donor, or recipient, for the purpose of monitoring the results of the donationor transplant, care maintenance and initiating post-donation or post-transplantation interventions

WHO Glossary

Human cells and tissuesfor transplantation

Articles containing or consisting of human cells and/or tissues that are intended for implantation, transplantation,infusion, or transfer into a human recipient. Examples include, but are not limited to, musculoskeletal tissue (bone,cartilage, and meniscus), skin, soft tissue (tendons, ligaments, nerves, dura mater, fascia lata and amniotic membrane),cardiovascular tissue (heart valves, arteries and veins), ocular tissue (corneas and sclera), bone marrow andhematopoetic stem/progenitor cells derived from peripheral and cord blood and stem cells of any tissue, andreproductive cells/tissues. The following articles are not included in HCTT1. Vascularized human organs2. Whole blood or blood components or blood derivative products3. Secreted or extracted human products, specifically milk, collagen, and cell factors;

Cells, tissues and organs derived from animals other than humansWHO Glossary

Imported/import Human bodies, body parts, cells, tissues and organs for human application, legally procured outside of thenational boundary to which it has been transported for use. Importation must be according to local(receiving country) laws and conventions and supplying country laws

WHO Glossary

Incompetent person An individual who is unable to make legally valid decisions or is deprived of his or her capacity to decide and/or understand the implications of his or her actions (e.g., a minor or individual legally declared unable tomanage their own affairs)

WHO Glossary

Living donor A living human being from whom cells, tissues or organs have been removed for the purpose oftransplantation. A living donor has one of three possible relationships with the recipient:

A/Related1. Genetically related

i. First-degree genetic relative: parent, sibling, offspringii. Second-degree genetic relative: grandparent, grandchild, aunt, uncle, niece, nephewiii. Other than first- or second-degree relative; for example cousin;

2. Emotionally related: spouse (if not genetically related), in-laws, adopted, friendB/Unrelated: not genetically or emotionally related

WHO Glossary

Opt-in system See Explicit consent

Opt-out system See Presumed consent

Organ Differentiated and vital part of the human body, formed by different tissues, that maintains its structure,vascularization and capacity to develop physiological functions with an important level of autonomy

EU Directive 2004

Organ characterization The collection of the relevant information on the characteristics of the organ needed to evaluate its suitability,in order to undertake a proper risk assessment and minimize the risks for the recipient, and optimize organallocation

EU Directive 2010

Organ exchangeorganization

A non-profit organization, whether public or private, dedicated to national and cross-border organ exchangeAdapted from EU Directive 2010

Organ replacementtherapy

Medical treatment for the purpose of prolonging life in the event of end-stage organ failure, includingtransplantation, renal dialysis, left ventricular assist device, etc. Also called “bridge therapy” where theintention is to sustain life in preparation for transplantation

Editorial Group, Madrid Consultation

Possible deceased organdonor

A patient with a devastating brain injury or lesion or a patient with circulatory failure who is apparentlymedically suitable for organ donation (see critical pathway)


Potential deceasedorgan donor

A person whose clinical condition is suspected to fulfill brain death criteria or a person whose circulatory andrespiratory functions have ceased and resuscitative measures are not to be attempted or continued or aperson in whom the cessation of circulatory and respiratory functions is anticipated to occur within a timeframe that will enable organ recovery (see critical pathway)


(Continued)




Preemptivetransplantation

The transplantation of an organ to a recipient who has not yet lost all function of that organ and is notreceiving another form of organ replacement therapy, but for whom end-stage organ failure is imminent


Preservation The use of chemical agents, alterations in environmental conditions, or other means to prevent or retardbiological or physical deterioration of organs from procurement to transplantation

EU Directive 2010

Presumed consent Legally valid presumption of permission for removal of cells, tissues and organs for transplantation, in theabsence of individual pre-stated refusal of permission. Otherwise known as “opting out”

WHO Glossary

Processing All operations involved in the preparation, manipulation, preservation and packaging of cells or tissuesintended for human application

EU Directive 2004

Procurement The process that includes donor identification, evaluation, obtaining consent for donation, donormaintenance and retrieval of cells, tissues, or organs

WHO Glossary

Procurementorganization

Any organization that undertakes or coordinates the procurement of human organs and is authorized to do soby the relevant authority


Recipient The human being into whom allogenic human cells, tissues or organs were transplantedWHO Glossary

Regulatory oversight The management or supervision of a group by an outside body in order to control or direct according to rule,principle, or law

WHO Glossary

Reimbursement Compensation for the costs involved in making donations, including medical expenses and loss of earnings forlive donors, on the basis of reasonable and verifiable claims


Retrieval or recovery The procedure of removing cells, tissues or organs from a donor for the purpose of transplantationWHO Glossary

Self-sufficiency Self-sufficiency in organ donation and transplantation means equitably meeting the transplantation needs of agiven population, using resources from within that population or through regional cooperation as required


Serious adverse event Any untoward occurrence associated with the procurement, testing, processing, storage, distribution,transplantation procedure itself, or post-transplantation management procedure of cells, tissues, and organs thatmight lead to the transmission of a communicable disease, to death or life threatening, disabling, or incapacitatingconditions for patients or which might result in, or prolong, hospitalization or morbidity

WHO Glossary

Serious adverse reaction An unintended response, including a communicable disease, in the donor or in the recipient, associated withthe procurement, the transplantation procedure itself or post-transplantation management procedure in thehuman application of cells, tissues, and organs that is fatal, life threatening, disabling, incapacitating orwhich results in, or prolongs, hospitalization or morbidity

WHO Glossary

Split liver A split liver transplant is defined when a donor liver is divided into parts and transplanted into more than onerecipient

WHO Glossary

Storage The maintenance of donor cells, tissues or organs under appropriate controlled conditions untiltransplantation or disposal

WHO Glossary

Surveillance The systematic ongoing collection, collation and analysis of data for public health purposes and the timelydissemination of public health information for assessment and public health response as necessary

International Health Regulations 2005

Surveillance system (forhuman cells, tissues andorgans for transplantation)

An established process at a local, regional or national level for the reporting of serious adverse events, seriousadverse reactions or complications related to donation, and transplantation of cells, tissues, and organs

WHO Glossary

Time on waiting list The time from placement on the waiting list for a transplant until the date of reporting (of a transplant) oruntil removal (from the waiting list)

WHO Glossary

(Continued)



Tissue All constituent parts of the human body formed by cellsEU Directive 2004

Tissue establishment A tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage, ordistribution of human tissues and cells are undertaken. It may also be responsible for procurement ortesting of tissues and cells

EU Directive 2004

Traceability The ability of an authorized organization to identify and locate all cells, tissues, or organs from all specificdonors at any time after donation, linked to all specific recipients and vice versa from recipients to donors.This traceability applies to any step of procurement, allocation, processing, including processing agents,storage, distribution, or disposal at any time after donation

WHO Glossary

Trafficking (cells, tissuesor organs)

The recruitment, transport, transfer, harboring, or receipt of living or deceased persons or their cells, tissues,or organs, by means of the threat or use of force or other forms of coercion, of abduction, of fraud, ordeception, of the abuse of power or of a position of vulnerability, or of the giving to, or the receiving by, athird party of payments or benefits to achieve the transfer of control over the potential donor, for thepurpose of exploitation by the removal of cells, tissues and organs for transplantation

WHO Glossary

Transplantcommercialism

A policy or practice in which cells, tissues, or organs are treated as a commodity, including by being bought orsold or used for material gain

WHO Glossary

Transplant tourism Travel for transplantation when it involves organ trafficking and/or transplant commercialism or if theresources (organs, professionals, and transplant centers) devoted to providing transplant to patients fromoutside a country undermine the country’s ability to provide transplant services for its own population

The Declaration of Istanbul

Transplantation The transfer (engraftment) of human cells, tissues or organs from a donor to a recipient with the aim ofrestoring function(s) in the body. When transplantation is performed between different species, forexample, animal to human, it is named xenotransplantation

WHO Glossary

Transplantation center A healthcare establishment, team or a unit of a hospital or any other body which undertakes thetransplantation of human organs, and is authorized to do so by the relevant authority


Travel fortransplantation

The movement of organs, donors, recipients or transplant professionals across jurisdictional borders fortransplantation purposes

The Declaration of Istanbul

Utilized deceased organdonor

An actual donor from whom at least one organ was transplanted (see Critical Pathway)Critical Pathway Working Group, Madrid Consultation

Waiting list The list of candidates registered to receive a human cell, tissue and organ transplantWHO Glossary

Waiting listmanagement

A system (or method) for maintaining a waiting list accuracy and currency, protecting the privacy, andconfidentiality of patients in the waiting list

WHO Glossary



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